Status:
Ready to upload
Record number:
1191
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
A total of 106 similar reactions have been reported, involving 74 patients in 14 US states related to a specific leukoreduction filter which has since been taken off the market.
Time to detection:
1 - 24 hours
Alerting signals, symptoms, evidence of occurrence:
On December 23, 1997, the Portland region of the American Red Cross (ARC) notified the Oregon Health Division about a cluster of adverse ocular reactions among six patients who had received out-patient red blood cell (RBC) transfusions at a hospital in Washington; all patients experienced severe bilateral conjunctival erythema within 24 hours of transfusion. From November 15, 1997, through January 7, 1998, a total of 49 adverse ocular reactions were reported in 38 patients in Michigan, Oregon, and Washington. An adverse ocular reaction was defined as bilateral eye redness occurring after November 1, 1997, and within 24 hours of receiving a RBC product. Median age of patients was 59 years (range: 28-84 years), and 22 (58%) were male; all had an underlying oncologic or hematologic diagnosis. Median time from transfusion initiation to symptom onset was 20 hours (range: 1-24 hours). Reactions were characterized by severe conjunctival erythema and/or conjunctival hemorrhage (100%), eye pain (62%), headache (25%), periorbital edema (23%), arthralgias (19%), nausea (15%), dyspnea (6%), and rash (6%). Median time from symptom onset to resolution was 5 days (range: 2-21 days); two patients remained symptomatic at the time of the interview. All patients had received transfusions of leukocyte-reduced RBCs within 24 hours of symptom onset; four also had received platelets. For 45 of 46 patients for whom information was available, the patient had received at least one unit of blood filtered with the LeukoNet Prestorage Leukoreduction Filtration System, one of several prestorage leukocyte-reducing methods used by ARC. In three reactions, patients also received blood filtered with another leukocyte-reducing prestorage method.
Demonstration of imputability or root cause:
Reactions related to a specific filter used for filtering red cell units. The filters were taken off the market.
Imputability grade:
3 Definite/Certain/Proven
Groups audience:
Keywords:
Suggest new keywords:
blood filters, prestorage
Suggest references:
Centers for Disease, Control and Prevention (CDC) (1998). Adverse ocular reactions following transfusions--United States, 1997-1998. MMWR Morb Mortal Wkly Rep. Jan 30;47(3):49-50.