BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 2576148 · Received May 8, 2012

    Report

    Report Number
    1722028-2012-00274
    Event Type
    Other
    Date Received
    May 8, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    CARIDIAN BCT
    Product Code
    LKN
    PMA / PMN Number
    K893962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE SEVERAL NURSES TAKING CARE OF THE PT DURING THE PROCEDURE. THE CUSTOMER STATED THAT THEY FELT IT MAY BE OPERATOR ERROR, AS THEY ARE NEW. THE OPERATOR REPORTEDLY KEPT PUSHING THE CONTINUE BUTTON WHEN RECEIVING THE SPILLOVER ALARMS INSTEAD OF ADDRESSING THE REPORTED CONDITION AND CONTINUED TO PULL RBCS OFF OF THE PT. FIELD DIAGNOSTIC/CORRECTION: A SERVICE TECHNICIAN EVALUATED THE MACHINE, REGARDING THE REPORT THAT THE STROBE WAS NOT WORKING. THEY WERE UNABLE TO DUPLICATE THE REPORTED CONDITION, BUT PRO-ACTIVELY REPLACED THE STROBE FLASH BULB. THE SPECTRA DISPOSABLE WAS RETURNED FOR INVESTIGATION. IT WAS NOTED THAT THE PRIME SALINE BAG WAS EMPTY UPON ARRIVAL. THE 4L WASTE BAG CONTAINED APPROX 1 LITER OF LIQUID TAKING ON THE APPEARANCE OF DILUTED WHOLE BLOOD. THE DISPOSABLE WAS INSPECTED FOR MISASSEMBLIES, MISSING PARTS, KINKS AND OTHER DEFECTS BUT NONE WERE FOUND. NO OCCLUSIONS WERE IDENTIFIED. THE CHANNEL APPEARED TO HAVE BEEN LOADED CORRECTLY. POSSIBLE CAUSES FOR RBC IN THE WASTE BAG: INCORRECT/INACCURATE HCT ENTERED FOR THE PROCEDURE. IF THE HCT WAS ENTERED TOO LOW, THE INTERFACE WOULD BE HIGHER AND COLLECTION WOULD HAVE CONSISTED OF PLASMA AND RBC. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MFG THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: OPERATOR ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AFTER NOTICING A LARGE AMOUNT OF RBC IN THE WASTE BAG DURING A TPE PROCEDURE. THE OPERATORS HAD BEEN GETTING SEVERAL SPILLOVER ALARMS. THEY WERE ABLE TO DO RINSEBACK AND COMPLETE THE PROCEDURE ON ANOTHER MACHINE WITHOUT COMPLICATIONS. THE PT WAS ADMITTED TO THE HOSPITAL AND TRANSFUSED 1 UNIT OF BLOOD. THE PT IS CURRENTLY IN STABLE CONDITION. THE DISPOSABLE KIT WILL BE RETURNED FOR INVESTIGATION. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL LKN CARIDIAN BCT 950000000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O| R