BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIPLER ARMY HONOLULU HI1

    MDR report key: 1739978 · Received June 25, 2010

    Report

    Report Number
    1718850-2010-00115
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 27, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST HAS BEEN MADE FOR PT INFO. THE FACILITY DID NOT PROVIDE THE LOT NUMBER. THE EXPIRATION DATE CANNOT BE DETERMINED. THE FACILITY DID NOT PROVIDE THE LOT NUMBER. THE MANUFACTURING DATE CANNOT BE DETERMINED. THE PERFUSIONIST REPORTED THAT THE TUBING DISCONNECTED FROM THE SARNS DELPHIN PUMP HEAD DURING THE PROCEDURE. SINCE NO PRODUCT WAS RETURNED FOR EVALUATION, ONE UN-USED SARNS DELPHIN PUMP AND STERILE SMA TUBING WERE USED FOR THIS INVESTIGATION. IT WAS REPORTED THAT THE CIRCUIT HAD BEEN SET-UP AND PRIMED APPROXIMATELY A WEEK PRIOR TO USE. THE HOSPITAL PERSONNEL MADE THE CONNECTION BETWEEN THE TUBING AND THE CENTRIFUGAL PUMP. A CIRCUIT WAS PRIMED AND ALLOWED TO SIT FOR SEVEN DAYS WITH THE CENTRIFUGAL PUMP IN A VERTICAL POSITION. THE TUBING WAS PUSHED PAST THE SECOND BARB WITH NO TYE WRAP. AFTER SEVEN DAYS, PRIME WAS CIRCULATED AT 6 LPM FOR SIX HOURS. THE CENTRIFUGAL PUMP WAS THEN SUBJECTED TO PULSATILE FLOW FOR SIX HOURS. NEXT, THE TUBING WAS REMOVED FROM THE PUMP AND A NEW PIECE OF TUBING WAS PLACED ON THE INLET PORT. THE TUBING WAS PUSHED JUST PAST THE FIRST BARB AND TYE WRAPPED IN PLACE. AGAIN, IN A VERTICAL POSITION, THE CIRCUIT WAS PRIMED, ALLOWED TO SIT FOR NINE DAYS AND THEN CIRCULATED AT 6 LPM FOR SIX HOURS. THE CENTRIFUGAL PUMP WAS AGAIN SUBJECTED TO PULSATILE FLOW FOR SIX HOURS. FINALLY, THE CENTRIFUGAL PUMP WAS ROTATED TO A HORIZONTAL POSITION. PRIME WAS CIRCULATED AT 6 LPM FOR 6 HOURS ON TWO SEPARATE DAYS. FOR ALL TESTS, THE SMA TUBING DID NOT FALL OFF OR DISCONNECT FROM THE SARNS PUMP HEAD AT REST OR DURING RE-CIRCULATION. PRODUCT WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE PHYSICAL PRODUCT, THE CAUSE OF THE REPORTED PROBLEM CANNOT BE DETERMINED. THERE WAS NO REPORT OF PATIENT INJURY. THE PATIENT DID RECEIVE BLOOD TO COMPENSATE FOR THE BLOOD LOSS. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT THE TUBING DISCONNECTED FROM THE CENTRIFUGAL PUMP DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. HOWEVER, THE PATIENT RECEIVED THREE UNITS OF BLOOD TO COMPENSATE FOR THE BLOOD LOSS DUE TO THE DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPLER ARMY HONOLULU HI1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1