BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL PURECEL PL

    MDR report key: 316496 · Received February 21, 2001

    Report

    Report Number
    2647898-2001-00001
    Event Type
    Death
    Date Received
    February 21, 2001
    Date of Event
    January 18, 2001
    Report Date
    January 22, 2001
    Manufacturer
    PALL BIOMEDICAL INC.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS ADMITTED IN 1/2001 FOR A SPLEENECTOMY DUE TO AN ENLARGED SPLEEN & CHRONIC THROMBOCYTOPENIA. FIVE DAYS LATER PT'S PLATELET COUNT WAS 64,000 AND 12 UNITS OF PLATELETS WERE ORDERED TO BE TRANSFUSED. THE LAB POOLED THEM INTO TWO BAGS. THE FIRST BAG WAS HUNG AT 2210. AT 2230 PT BEGAN COMPLAINING OF INCREASED BACK PAIN & WAS SHAKING. THE INFUSION WAS STOPPED. THE PT SEEMED TO IMPROVE. THE PHYSICIAN WAS CALLED & ORDERED BENADRYL AND CONTINUATION OF THE TRANSFUSION USING A LR FILTER. THE NURSE INADVERTENTLY HUNG A RED CELL FILTER BUT DISCONTINUED IT AFTER A COUPLE OF MINUTES OF INFUSION. SHE THEN HUNG THE PL6T AS ORDERED AT 2300. THE PT'S VITAL SIGNS REMAINED STABLE BUT THE O2 SAT DROPPED AT 2330 TO THE MID-80S. PT WAS PLACED ON OXYGEN. AT 0010 THE PT WAS NOTIFIED OF INCREASED RESPIRATORY DISTRESS AND ORDERED LASIX. AT 0040 PT'S VITALS WERE STABLE BUT THEIR SATURATION DROPPED AGAIN & PT WAS PLACED ON 100% NON-BREATHING OXYGEN TO MAINTAIN THEIR SATURATION AND WAS ORDERED TO BE TRANSFERRED TO THE ICU. BOTH BAGS OF PLATELETS HAD BEEN INFUSED. ON THEIR WAY TO THE UNIT, PT CODED AND DIED. NO AUTOPSY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6802 PALL PURECEL PL LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSION CAK PALL BIOMEDICAL INC. PL6T 027607

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death