BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED APHERESIS KIT, PL732, 600 ML TRANSFER PACK

    MDR report key: 166410 · Received May 6, 1998

    Report

    Report Number
    2314912-1998-00004
    Event Type
    Malfunction
    Date Received
    May 6, 1998
    Date of Event
    April 19, 1996
    Report Date
    May 5, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE CONCLUSION OF AN APHERESIS PROCEDURE THE NURSE NOTICED THAT THE DONOR DELVELOPED REDNESS AND WELTS AT THE VENIPUNCTURE SITE. NO MEDICATION WAS GIVEN TO THE DONOR. THIS INDIVIDUAL WAS A FREQUENT DONOR WITH NO HISTORY OF ALLERGIES. THE DONOR WAS RELEASED IN GOOD CONDITION. THIS EVENT WAS NOT REPORTED TO THE FDA UNTIL AFTER THE INSPECTION AND WAS THEN REPORTED AS AN ADVERSE REACTION/OTHER. THIS DONOR HAD A POSITIVE RAST TEST RESULT THAT WAS 25.8 INDICATING THAT SIGNIFICANT LEVELS OF IGE SPECIFIC FOR ETHYLENE OXIDE (ETO-HSA) WERE DETECTED. BAXTER, INC CONSULATATION WITH THE FENWAL DIV MEDICAL DIRECTOR, RECOMMENDED THAT ANY DONOR WITH A POSITIVE RAST TEST BE DEFERRED FROM FURTURE APHERESIS DONATIONS. THE CLINICAL SYMPTOMS DISPLAYED BY THIS APHERESIS DONOR AND THE POSTIVE DONOR RAST TEST MAY INDICATE DONOR HYPERSENSITIVITY. HYPERSENSITIVE DONORS MAY EXPERIENCE ADVERSE PHYSIOLOGIC REACTIONS WHEN EXPOSED TO MEDICAL DEVICES STERILIZEA WITH ETHYLENE OXIDE. IN VIEW OF THE FACT THAT NO MEDICATIONS WERE ADMINISTERED TO THE APHERESIS DONOR, THE APHERESIS PROCEDURE WAS NOT DISCONTINUED, THIS EVENT SHOULD HAVE BEEN REPORTED TO THE FDA IN ACCORDANCE WITH THE PROVISIONS OF 21 CFR PART 803 AS AN MDR MALFUNCTION REPORT. YOU SOULD SUBMIT AN MDR SUPPLMENTAL REPORT TO FDA REGARDING THIS MALFUNCTION REPORT FOLLOWING THIS CORRESPONDENCE.

    Description of Event or Problem · 1

    AT THE END OF PLATELETPHERESIS PROCEDURE THE NURSE NOTICED THAT AT THE VENIPUNCTURE SITE THE DONOR HAD DEVELOPED REDNESS AND WELTS. NO MEDICATION WAS GIVEN. THE DONOR WAS RELEASED IN GOOD CONDITION. THIS IS A FREQUENT DONOR WITH NO HISTORY OF ALLERGIES. THE NURSE REQUESTED TO HAVE THE DONOR TESTED FOR A POSSIBLE ETHYLENE OXIDE SENSITIVITY. BLOOD SAMPLES WILL BE ANALYZED BY BAXTER/FENWAL FOR A POSSIBLE ETHYLENE OXIDE SENSITIVITY. ON 11/12/1996, 11/13/1996 & 12/18/1996 PMQA FOLLOWED UP WITH THE CUSTOMER TO SEE WHEN THE BLOOD WOULD BE DRAWN FOR ETHYLENE OXIDE TESTING. THE DONOR LIVES FAR FROM THE CENTER AND WAS ADVISED BY THE CENTER HE COULD NOT DONATE AGAIN UNTIL THE TESTING IS COMPLETED. BLOOD SAMPLES FOR ETHYLENE OXIDE RADIOALLERGO SORBENT TESTING WERE RECEIVED BY BAXTER FENWAL ON 1/28/1997. TEST RESULTS INDICATED 25.8 KU/L. THE BLOOD CENTER WAS NOTIFIED OF THESE RESULTS VIA LETTER ON 2/10/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSED APHERESIS KIT, PL732, 600 ML TRANSFER PACK CLOSED APHERESIS KIT, PL732, 600 ML TRANSFER PACK GKT BAXTER HEALTHCARE CORP NA H96B23029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other