BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI SET

    MDR report key: 3070566 · Received April 17, 2013

    Report

    Report Number
    8030665-2013-00213
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    REYNOSE MANUFACTURING
    Product Code
    FKJ
    PMA / PMN Number
    96-2081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL; HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT WAS RETURNED FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATION OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR #S 8030665-2013-00214, 8030665-2013-00215, 8030665-2013-00216, 8030665-2013-00217, 8030665-2013-00218.

    Description of Event or Problem · 1

    A CHIEF TECH HAS REPORTED THAT A BLOOD LEAK OCCURRED DURING TREATMENT. THE TRANSDUCER PROTECTOR AND TRANSDUCER LINE SEPARATED DURING TREATMENT AND BLOOD SPRAYED EVERYWHERE. THE CHIEF TECH MENTIONED THAT IT HAS BEEN A RECURRING ISSUE. ESTIMATED BLOOD LOSS WAS LESS THAN 100 CC'S. PTS DID NOT REQUIRE MEDICAL INTERVENTION. THE ACTUAL SAMPLE WAS DISCARDED; A COMPANION SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164657 COMBI SET HEMODIALYSIS BLOODLINE FKJ REYNOSE MANUFACTURING 12NR01240

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS DIALYZER| HEMODIALYSIS MACHINE