Adverse Reactions Associated with Midline Catheters -- United States, 1992-1995

The midline catheter is a peripherally inserted 6-8-inch catheter that may be used in patients requiring intermediate duration (i.e., several weeks) of physiologically compatible intravenous (IV) therapy. Unlike conventional short peripheral IV catheters, the midline catheter does not require changes every 48-72 hours. * Midline catheters can be inserted at the bedside by a trained health-care worker, in contrast to subclavian, jugular, or femoral central venous catheters, which require insertion by a physician (often in an operating or procedure room) and usually are associated with more serious complications. Since 1990 (1), the Food and Drug Administration (FDA) has received reports of acute hypersensitivity-like reactions temporally associated with insertion of midline catheters made from Aquavene{Registered} (Landmark{Registered}, Menlo Care, Menlo Park, California) **, an elastomeric hydrogel material that becomes hydrated and expands after catheter insertion (FDA, unpublished data, 1995; 1). This report describes four episodes of such reactions during 1992-1995, including one in a patient in a home-health-care setting (patient

1. and three among patients at a large university-affiliated hospital (patients 2-4).

Patient 1. A 31-year-old woman in the first trimester of pregnancy required home hydration therapy for management of hyperemesis gravidarum. She had received IV lactated Ringers solution at home beginning March 21, 1992, using Teflon{Registered} catheters without complications. On April 24, 1992, a Landmark{Registered} catheter was placed because of the long-term nature of the therapy and diminished peripheral access. On flushing the catheter with 5 mL of 0.9% saline, the patient complained of chest pain, shortness of breath, and a sense of "impending doom." Facial flushing and urticaria were noted on the upper chest. In response to the symptom onset, the catheter was immediately removed, and the symptoms resolved within minutes. The patient remained hemodynamically stable and was treated with diphenhydramine. Subsequently, she received hydration therapy using Teflon{Registered} catheters without further complications.

Patient 2. A 35-year-old woman was admitted to the hospital in January 1994 because of complications from a bile leak following a cholecystectomy. Fourteen days after admission, a Landmark{Registered} midline catheter was inserted into her right antecubital vein. Within 1-2 minutes of inserting the catheter and flushing with 0.9% saline, the patient complained of back pain and shortness of breath, and her skin became flushed; no IV medication had been administered before onset of symptoms. The catheter was removed immediately, and all symptoms resolved within 5-10 minutes without further intervention. The patient had no known allergies and had had other types of IV catheters inserted before and after this event without similar complications.

Patient 3. A 75-year-old woman with no known allergies was admitted to the hospital with endocarditis in February 1994 and had a Landmark{Registered} midline catheter placed in a right antecubital vein 13 days after admission. Following flushing with 0.9% saline, maintenance IV fluid (0.9% saline) was begun; 20-30 minutes later, but before administration of any IV medications, she complained of chest tightness. She was noted to be "shaking profusely" and confused, and her skin was mottled. IV hydrocortisone, diphenhydramine and meperidine were administered, and the catheter was removed. Her symptoms resolved within 5-10 minutes of catheter removal. Blood and urine cultures were negative. IV catheters made by other manufacturers have been inserted in this patient before and after this event without similar complications.

Patient 4. A 14-year-old girl with cystic fibrosis and no known allergies was admitted to the hospital in July 1994 because of an exacerbation of her underlying respiratory condition. She previously had a midline catheter placed while at home without complications; the manufacturer of that catheter is unknown. The day after admission, a Landmark{Registered} midline catheter was placed in her left antecubital vein. Within 1-2 minutes after insertion and flushing with 0.9% saline, and as maintenance IV fluid (5% dextrose in 0.45% saline) was started, she became nauseated and complained of blurred vision and shortness of breath. Her skin was flushed with central cyanosis. She was diaphoretic, gasping, and lost consciousness. The catheter was removed, and she regained consciousness and her other symptoms resolved within 5-10 minutes after removing the catheter without any other interventions. Since the episode, IV catheters made by other manufacturers have been inserted in this patient without similar complications.

Other reports. From April 1990 through July 1995, a total of 72 adverse reactions similar to those described in this report were reported to FDA (FDA, unpublished data, 1995; 1). At the hospital involved in this report, 292 Landmark{Registered} midline catheters were inserted from January 1993 through September 1994; the three episodes of acute hypersensitivity-like reactions occurred during this period. In addition, 70,838 other types of catheters made by other manufacturers were inserted at that hospital during this period without adverse effects.

Reported by: L Mermel, DO, SM Tow, Dept of Medicine and Dept of Nursing, Rhode Island Hospital, Providence; M Mahoney, Rhode Island Home Therapeutics, East Providence. Hospital Infections Program, National Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: The cause of the adverse reactions temporally associated with the insertion of midline IV catheters described in this report is unknown. Acute hypersensitivity reactions associated with inserting or flushing IV catheters is rarely reported. The acute onset of flushing in the patients described in this series of case reports suggests several possibilities, including hypersensitivity; the common, temporally associated exposures among the four patients were the insertion of a Landmark{Registered} midline catheter and flushing of the catheter with 0.9% sterile saline. Possible sources for reactions include catheter components, intrinsic or extrinsic material on the inside or outside of the catheter, residual material associated with catheter sterilization or packaging, injectable fluids and medications, anatomic location of the catheter insertion, or insertion technique. However, none of these patients had received any IV medication before the reaction. Although all the patients had flushes with 0.9% saline, the type of flushes and IV fluids that they had received were the same as those that other patients had received or the same as those that they had received with other catheters before and after the reactions without problems; however, whether these other catheters were midline catheters is unknown.

The Landmark{Registered} catheter is the only midline catheter manufactured from Aquavene{Registered}. Latex, a material previously known to have caused hypersensitivity reactions (2,3), is not a component of the catheter. Reported reactions often have occurred during flushing, suggesting the cause of the reactions may be extrinsic to the catheter and is dislodged during flushing. Midline catheters are sterilized by irradiation, which excludes the possibility of residues from chemical disinfectants such as formaldehyde or ethylene oxide -- compounds associated with hypersensitivity reactions (4,5). Allergens may adhere to the wall of the catheter or have a threshold that must be reached, as suggested by the delayed onset in the acute hypersensitivity-like reaction 20-30 minutes after insertion in one patient (patient 3) -- the approximate time required for the catheter to become completely hydrated and the lumen partially opened. In addition, the hydration process may facilitate the release of the causative agent.

Because of the rare occurrence of acute hypersensitivity reactions associated with the insertion or flushing of IV catheters, the association between these reactions and one or more catheters may be difficult to recognize at any single institution and may depend on the frequency of use of the catheter. Further investigation is necessary to determine the cause of the reactions, the prevalence of such reactions, and whether these reactions occur with catheters made of other materials (1,6,7). To determine whether these reactions are associated with the midline catheter, the manufacturer is working with FDA on further studies. Health-care workers who observe reactions associated with IV devices are encouraged to report their findings to the FDA Medwatch Program (telephone {800} 332-1088) and through their state health department to the CDC Hospital Infections Program, National Center for Infectious Diseases (telephone {404} 639-6413).

References

1. Mermel L, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. Ann Intern Med 1995;123:841-4.

2. Sussman GL, Beezhold DH. Allergy to latex rubber. Ann Intern Med 1995;122:43-6.

3. CDC. Anaphylactic reactions during general anesthesia among pediatric patients -- United States, January 1990-January 1991. MMWR 1991;40:442-3.

4. Bousquet J, Michel FB. Allergy to formaldehyde and ethylene-oxide. Clin Rev Allergy 1991; 9:357-70.

5. Masin G, Polenakovic, Ivanovski N, et al. Hypersensitivity reactions to ethylene oxide: clinical experience. Nephrology, Dialysis, Transplantation 1991;6(suppl 3):50-2.

6. Maki D. Reactions associated with midline catheters for intravenous access. Ann Intern Med 1995;123:884-6.

7. Blum DY. Untoward events associated with use of midterm I.V. devices. J Intravenous Nurs 1995;18:116-9.

• 60 FR 49,978-50,006. ** Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

  
  

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