BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERF ALLIANCE OK CITY OK 1

    MDR report key: 2576175 · Received May 11, 2012

    Report

    Report Number
    1718850-2012-00047
    Event Type
    Other
    Date Received
    May 11, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 11, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE BLOOD DIDN'T APPEAR TO CHANGE COLOR AS EXPECTED SO THE PERFUSIONIST WAS CONCERNED THAT THE OXYGENATOR MAY NOT HAVE BEEN OXYGENATING PROPERLY. UPON INSPECTION OF THE CIRCUIT, THE PERFUSIONIST FOUND THAT THE OXYGENATOR INLET AND OUTLET LINES HAD BEEN CONNECTED IN REVERSE. THE INLET LINE WAS CONNECTED TO THE OUTLET OF THE OXYGENATOR AND VICE VERSA. IN RESPONSE TO THE ISSUE, THE USER REPLACED THE ENTIRE CIRCUIT AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO INJURY TO THE PT. IT WAS LATER REPORTED THAT THE PT HAS BEEN RELEASED FROM THE HOSPITAL AND IS DOING WELL. THE OXYGENATOR AND CIRCUIT WERE RETURNED TO SORIN GROUP FOR EVAL. VISUAL INSPECTION OF THE CIRCUIT CONFIRMED THAT IT HAD BEEN ASSEMBLED INCORRECTLY. PERFORMANCE TESTING WAS PERFORMED ON THE RETURNED OXYGENATOR AND ON A CONTROL UNIT FROM INVENTORY. BOTH THE RETURNED UNIT AND CONTROL WERE TESTED ONCE WITH THE INLET/OUTLET LINES IN THE "CORRECT" ORIENTATION AND ONCE WITH THE LINES REVERSED. THIS TESTING FOUND THAT THE PERFORMANCE OF THE RETURNED UNIT WAS COMPARABLE TO THAT OF THE CONTROL UNIT AND THAT HAVING THE LINES CONNECTED IN REVERSE DID NOT AFFECT GAS TRANSFER OF EITHER DEVICE. BASED ON THE LABORATORY TESTING, THE RETURNED PRIMOX WAS FOUND TO BE FUNCTIONALLY SOUND AND CAPABLE OF MEETING A PT'S METABOLIC DEMANDS IN BOTH ORIENTATIONS. ALTHOUGH TESTING FOUND THAT THE MISSASSEMBLY DID NOT NEGATIVELY AFFECT THE DEVICE'S PERFORMANCE, IN ORDER TO PREVENT A RE-OCCURRENCE, THE PERSONNEL RESPONSIBLE FOR THE ASSEMBLY AND INSPECTION OF THIS LOT HAVE BEEN RETRAINED. NO FURTHER ACTION IS DEEMED NECESSARY. THE INCORRECT ORIENTATION CAUSED THE PERFUSIONIST TO CHANGE OUT THE DEVICE; THIS HOWEVER, DID NOT CAUSE PT INJURY. CHANGING OUT THE CIRCUIT TOOK OVER 3 MINUTES. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THE LENGTH OF TIME REQUIRED TO CHANGE THE UNIT OUT.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE BLOOD DIDN'T APPEAR TO CHANGE COLOR AS EXPECTED SO THE PERFUSIONIST WAS CONCERNED THAT THE OXYGENATOR MAY NOT HAVE BEEN OXYGENATING PROPERLY. UPON INSPECTION OF THE CIRCUIT, THE PERFUSIONIST FOUND THAT THE OXYGENATOR INLET AND OUTLET LINES HAD BEEN CONNECTED IN REVERSE. THE INLET LINE WAS CONNECTED TO THE OUTLET OF THE OXYGENATOR AND VICE VERSA. IN RESPONSE TO THE ISSUE, THE USER REPLACED THE ENTIRE CIRCUIT AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO INJURY TO THE PT. IT WAS LATER REPORTED THAT THE PT HAS BEEN RELEASED FROM THE HOSPITAL AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERF ALLIANCE OK CITY OK 1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1207200043

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR