BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL EZ PRIME

    MDR report key: 1052887 · Received May 27, 2008

    Report

    Report Number
    MW5007049
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 27, 2008
    Manufacturer
    PALL CORPORATION
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BEDSIDE LEUKOREDUCTION FILTER "LEAKED" DURING PRIMING AND A SPECIALLY PHENOTYPED UNIT OF RED CELLS WAS WASTED. THE SET AND ATTACHED UNIT WERE RETURNED TO BLOOD BANK, AND IT WAS OBSERVED THAT THE TUBING HAD DETACHED FROM JUNCTURE AT AIR VENT ASSEMBLY. THE EXPERIENCED NURSE SAID THE TUBING HAD NEVER BECOME DETACHED BEFORE, BUT SHE REMEMBERED SOME EVENTS IN 2007 IN WHICH THE AIR VENT ASSEMBLY HAD LEAKED, AND SHE THOUGHT THOSE LOTS HAD BEEN REMOVED FROM INVENTORY. NAVAL MED CENTER, BLOOD BANK AT THAT TIME HAD CONFERRED WITH THE COMPANY, PALL, AND RECEIVED A LETTER REGARDING A "COSMETIC CHANGE" THAT HAD BEEN MADE TO THE AIR ELIMINATION VENT DESIGN, BUT THERE WAS NO RECALL OF ANY LOT NUMBERS LISTED. NMCP ASKED FOR THE DATE OF THE MANUFACTURING CHANGE IN ORDER TO PULL ALL PREVIOUSLY MANUFACTURED SETS OUT OF USE, 8 BOXES, AND HAD RETURNED THEM FOR CREDIT. AFTER TODAY'S EVENT WE RECONTACTED PALL, WHO EXPLAINED THAT THE AIR VENT ASSEMBLIES ARE MADE BY A DIFFERENT MANUFACTURER AND LOTS CAN BE RELEASED OUT OF ORDER. WE PULLED 2 MORE FILTER SETS FROM LOT 0650252 WHICH THE TUBING DETACHED ON THE WARD AND 1 WAS VERY LOOSE AND CAME APART AS IT WAS REMOVED FROM THE PACKAGE. THE OTHER ONE REMAINED INTACT. THE QA DEPARTMENT ASKED THAT WE LIST ALL LOTS IN STOCK BEGINNING WITH "065" AND THEY WILL CHECK THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL EZ PRIME BEDSIDE LEUKOREDUCTION FILTER FOR RED BLOOD CELLS CAK PALL CORPORATION EZ PRIME 0650252

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other