BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI SET

    MDR report key: 3070545 · Received April 17, 2013

    Report

    Report Number
    8030665-2013-00215
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    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 DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER WITHIN A ONE MONTH DATE OF THE EVENT. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR #S 8030665-2013-00213, 8030665-2013-00214, 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 DISCONNECTED DURING TREATMENT. THE CHIEF TECH MENTIONED THAT IT HAS BEEN A RECURRING ISSUE. ESTIMATED BLOOD LOSS WAS LESS THAN 100CC'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
    165625 COMBI SET HEMODIALYSIS BLOODLINE FJK REYNOSA MANUFACTURING 12NR01240

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE| HEMODIALYSIS DIALYZER