BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLS CUSTOM PACK WITH QUADROX

    MDR report key: 5468136 · Received February 29, 2016

    Report

    Report Number
    2248146-2016-00018
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    January 29, 2016
    Report Date
    January 30, 2018
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    PMA / PMN Number
    K08059223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    02/29/2016 10:45 AM (GMT-5:00) ADDED BY (B)(4): THE PRODUCT WAS NOT RETURNED AND COULD NOT BE EVALUATED. IF IT IS RETURNED OR ADDITIONAL INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    DATES WERE NOT ENTERED IN THE INITIAL MDR. DATE OF THIS REPORT: 02/01/2016. DATE OF MANUFACTURER: 02/01/2016.

    Description of Event or Problem · 1

    02/09/2016 09:26 AM (GMT-5:00) ADDED BY (B)(4)):ACCOUNT REPORTS THAT ON 3 SEPARTE OCCASIONS THEY HAVE SEEN AIR IN THE OXYGENATOR AFTER THE CIRCUIT IS PRIMED. THE 3 CIRCUITS HAD ALL BEEN PRE-PRIMED READY FOR USE. THE FIRST AND SECOND CIRCUIT AIR WAS VISUALIZED AT 28 DAYS AFTER PRE-RIME AND THE THIRD CIRCUIT AFTER 11 DAYS OF PRE-PRIME. AIR WAS NOTED TO BE HALF WAY UP ON THE VENOUS SIDE OF THE OXYGENATOR AND ABOUT 1/4 OF THE WAY UP ON THE ARTERIAL SIDE, NO AIR WAS VISUALIZED IN THE TUBING OR OTHER COMPONENTS. EACH OF THE CIRCUITS WERE CAUGHT BEFORE USE ON A PATIENT THEY WERE BEING HELD IN A CLOSET DESGINATED FOR PRE-PRIMED CIRCUITS ON THE ICU FLOOR, TWO OF THE CIRCUITS WERE DISPOSED OF AND THE THIRD CIRCUIT IS BEING RETAINED FOR USE IN TRAINING THE ACCOUNT DOES NOT WANT TO SEND IT BACK TO MAQUET FOR EVALUATIONTHIS WAS REPORTED IN THE CP PRODUCT COMPLAINBT DEPT, I WAS ASKED TO NOW PUT INT TO THE CA PRODUCT COMPLAIBT DATA BASE ORGINIAL (B)(4) EVENT WAS REPORTED (B)(6) 2016 SAME DAY AS I WAS NOTIFIED BY (B)(4).

    Description of Event or Problem · 1

    (B)(4). ACCOUNT REPORTS THAT ON 3 SEPARATE OCCASIONS THEY HAVE SEEN AIR IN THE OXYGENATOR AFTER THE CIRCUIT IS PRIMED. THE 3 CIRCUITS HAD ALL BEEN PRE-PRIMED READY FOR USE. THE FIRST AND SECOND CIRCUIT AIR WAS VISUALIZED AT 28 DAYS AFTER PRE-RIME AND THE THIRD CIRCUIT AFTER 11 DAYS OF PRE-PRIME. AIR WAS NOTED TO BE HALF WAY UP ON THE VENOUS SIDE OF THE OXYGENATOR AND ABOUT 1/4 OF THE WAY UP ON THE ARTERIAL SIDE, NO AIR WAS VISUALIZED IN THE TUBING OR OTHER COMPONENTS. EACH OF THE CIRCUITS WERE CAUGHT BEFORE USE ON A PATIENT THEY WERE BEING HELD IN A CLOSET DESIGNATED FOR PRE-PRIMED CIRCUITS ON THE ICU FLOOR, TWO OF THE CIRCUITS WERE DISPOSED OF AND THE THIRD CIRCUIT IS BEING RETAINED FOR USE IN TRAINING THE ACCOUNT DOES NOT WANT TO SEND IT BACK TO MAQUET FOR EVALUATION THIS WAS REPORTED IN THE CP PRODUCT COMPLAINT DEPT, I WAS ASKED TO NOW PUT INT TO THE CA PRODUCT COMPLAINT DATA BASE ORIGINAL TRACKWISE NUMBER (B)(4). EVENT WAS REPORTED (B)(6) 2016 SAME DAY AS I WAS NOTIFIED BY ACC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122924 ECLS CUSTOM PACK WITH QUADROX TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1