BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMICUS APHERSIS KIT WITH DOUBLE NEEDLE W/ INL

    MDR report key: 1004835 · Received February 29, 2008

    Report

    Report Number
    2648979-2008-00001
    Event Type
    Injury
    Date Received
    February 29, 2008
    Date of Event
    January 9, 2008
    Report Date
    February 25, 2008
    Manufacturer
    FENWAL INC.
    Product Code
    GKT
    PMA / PMN Number
    BK050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED TO FENWAL FOR EVAL. A TWO YR REVIEW OF PROD CODE 4R2341 DID NOT IDENTIFY ANY SIMILAR REPORTS. A REVIEW OF THE COMPLAINT LOT N07I20010, DID NOT REVEAL ANY SIMILAR REPORTS OF SUSPECTED BACTERIAL CONTAMINATION. THE MFG FACILITIES REVIEWED BATCH RECORDS FOR THIS AND SURROUNDING BATCHES, WHICH INCLUDED STERILITY TEST RESULTS, PYROGEN TESTING, BIOBURDEN, INPROCESS & FINAL CHEMICAL ANALYSIS, PARTICLE ANALYSIS, SOLUTION FILTER TESTING, WITH NO EXCEPTIONS NOTED AND ALL RESULTS WITHIN APPLICABLE SPEC. PER FENWAL MEDICAL DIR: SEPTIC REACTIONS ARE RECOGNIZED ADVERSE EVENTS ASSOCIATED WITH PLATELETS TRANSFUSION. THEY USUALLY OCCUR DUE TO BACTERIAL CONTAMINATION DURING COLLECTION. RECENT DATA INDICATE THAT BACTERIAL CULTURES ON DAY ONE AFTER COLLECTION MISSES ABOUT 50% OF BACTERIAL CONTAMINATED UNITS. BASED ON INFO REC'D AND REVIEWED NO CAUSALITY RELATIONSHIP BETWEEN THIS EVENT AND FENWAL AMICUS APHERESIS KIT HAS BEEN IDENTIFIED. THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A REPORT WAS REC'D THAT A SINGLE PLATELET DONATION OF 600 ML, WAS SPLIT INTO 3 PRODS AND TRANSFUSED TO 3 SEPARATE PTS. EACH PT EXPERIENCED SYMPTOMS FOLLOWING THEIR TRANSFUSIONS THAT THE CUSTOMER FEELS ARE ASSOCIATED WITH THE SPLIT PROD. TWO OF THE THREE PRODS WERE TESTED BY THE TRANSFUSING FACILITY AND TESTED POSITIVE FOR COAG-NEG STAPH. THIS REPORT IS FOR PT # 1. PP1: ADULT FEMALE ONCOLOGY PT EXPERIENCED FEVER/ILLNESS AFTER RECEIVING ABOVE REFERENCED PLATELETS IN AN OUTPATIENT CLINIC. SHE WAS LATER ADMITTED TO THE HOSP THROUGH THE ER AND GIVEN ANTIBIOTICS. SYMPTOMS RESOLVED. THIS PT HAD PRIOR TRANSFUSIONS AND CONTINUES TO RECEIVE BLOOD PRODS AS AN OUTPATIENT AS CONTINUED TREATMENT FOR HER MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS APHERSIS KIT WITH DOUBLE NEEDLE W/ INL AMICUS DISPOSABLE KIT GKT FENWAL INC. NA N07I20010

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization AMICUS SEPARATOR