BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCONCENTRATOR BC 20 PLUS

    MDR report key: 5540854 · Received April 1, 2016

    Report

    Report Number
    8010762-2016-00231
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    November 18, 2015
    Report Date
    January 12, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KDI
    PMA / PMN Number
    K123288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS) IS REGISTERED UNDER 510(K): K123288. (B)(4). MAQUET CARDIOPULMONARY (B)(4) REQUESTED ADDITIONAL PRODUCT INFORMATION AND RETURN OF THE DEVICE BUT HAS NOT RECEIVED EITHER. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY REQUESTED THE PRODUCT BACK FOR INVESTIGATION BUT ON 2016-06-08 THE MANUFACTURER WAS INFORMED THAT PRODUCT WILL NOT BE AVAILABLE FOR INVESTIGATION. THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED BY (B)(4). STI. THEREBY NO ABNORMALITY WAS FOUND FOR THE RELATED MATERIAL. A REVIEW FOR SIMILAR COMPLAINTS FOR THE SPECIFIC PRODUCT HAS BEEN PERFORMED AND NO SIMILAR INCIDENT WITH A FAILURE CONFIRMED WAS FOUND. BASED ON THIS A CONFIRMATION OF THE FAILURE IS NOT POSSIBLE. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS AN SYSTEMATIC ERROR. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLOOD LEAKAGE FROM THE EFFLUENT OUTLET OF THE HEMOCONCENTRATOR. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED ON: PRODUCT WAS REPLACED DURING TREATMENT. NO DELAY IN TREATMENT. NO CONSEQUENCE FOR THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197888 HEMOCONCENTRATOR BC 20 PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MAQUET CARDIOPULMONARY AG BC 20 PLUS 92161836

    Patients

    Seq Age Sex Outcome Treatment
    1