BEUDAMED
    FDA Adverse Event Other Summary report: N

    UPMC PASSAVANT PITTSB PA 2

    MDR report key: 3684050 · Received March 7, 2014

    Report

    Report Number
    1718850-2014-00086
    Event Type
    Other
    Date Received
    March 7, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 4, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTN
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE MANUFACTURE DATE IS UNK. THE TERUMO RESERVOIR AND THE TUBING WHICH HAD BEEN ATTACHED TO THE OUTLET PORT WERE RETURNED TO SGU FOR EVAL. DIMENSIONAL ANALYSIS OF THE RETURNED TUBING FOUND THAT THE INNER DIAMETER OF THE RETURNED TUBING WAS WELL BELOW THE UPPER SPECIFICATION LIMIT AT ALL MEASUREMENT LOCATIONS, INCLUDING THE END WHICH HAD BEEN CONNECTED TO THE RESERVOIR. THE RETURNED TUBING WAS RE-CONNECTED TO THE OUTLET PORT OF THE RETURNED RESERVOIR AND A 5KG WEIGHT WAS HUNG FROM THE TUBING FOR 2 HOURS. THE TUBING REMAINED CONNECTED SECURELY TO THE PORT THROUGHOUT THE DURATION OF THE TEST. THE EVAL SUMMARIZED ABOVE FOUND NO EVIDENCE TO SUGGEST THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS CAUSED BY A PROBLEM WITH THE TUBING. ALTHOUGH THE ROOT CAUSE FOR THE DISCONNECTION COULD NOT BE CONFIRMED, INSPECTION OF THE RETURNED RESERVOIR FOUND THAT THE OUTLET PORT HAS A TAPERED, CONICAL SHAPE AND WITH LESS PRONOUNCED BARBS.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TUBING FROM A SORIN GROUP HEART LUNG PACK DISCONNECTED FROM THE OUTLET PORT OF A TERUMO RESERVOIR DURING SET-UP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139557 UPMC PASSAVANT PITTSB PA 2 CUSTOMER PERFUSION PACK DTN SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA