BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMASATE

    MDR report key: 6016750 · Received October 11, 2016

    Report

    Report Number
    3003591774-2016-00002
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    GAMBRO DASCO SPA
    Product Code
    KPO
    PMA / PMN Number
    K072908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT FAILURE COULD BE IDENTIFIED IN THE ABSENCE OF A COMPLAINT SAMPLE AND ALL INSPECTIONS AND RELEASE DOCUMENTS GIVE EVIDENCE THAT THE PRODUCT MEETS THE TECHNICAL SPECIFICATIONS. BATCH (B)(4) WAS PRODUCED ACCORDING TO SPECIFICATIONS AND THE INTERNAL APPROVED PROCEDURES. THE FILM USED TO PRODUCE THE EMPTY BAGS IS PROVIDED BY A SUPPLIER WHO CONFIRMED THAT NO CHANGES ON THE MATERIAL HAS BEEN RECENTLY IMPLEMENTED AND NO ANOMALIES HAVE BEEN OBSERVED ON THE BATCH OF FILM USED FOR THE EMPTY BAGS. MAINTENANCE AND CALIBRATION ACTIVITIES OF EQUIPMENT INVOLVED FOR EMPTY BAGS PRODUCTION WERE CHECKED AND NO DEVIATION WAS FOUND. MOREOVER, NO CHANGES INVOLVING ACTIVITIES THAT COULD HAVE AN IMPACT ON THE PRODUCTION LINE HAS BEEN RECORDED. TRACEABILITY OF EMPTY BAGS USED IN BATCH (B)(4) WERE USED IN 8 FINISHED PRODUCT BAGS; NO OTHER COMPLAINTS WERE RECEIVED. RETAINED SAMPLES OF EMPTY BAGS AND FINISHED PRODUCTS HAVE BEEN INSPECTED AND NO DEFECT HAS BEEN DETECTED. BATCH RECORDS HAVE BEEN REVIEWED AND NO DEVIATION OR SCRAPED PRODUCT FOR LEAKAGE HAS BEEN FOUND. FULL TRACEABILITY OF BATCH (B)(4) FOR DISTRIBUTION IN US CLINICS HAS BEEN PERFORMED. (B)(4). THERE HAVE BEEN NO OTHER COMPLAINTS FROM ANY OTHER CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT IDENTIFY ANY ANOMALIES. REVIEW OF THE COMPLAINT DATABASE IDENTIFIED A TOTAL 0F 4 SIMILAR EVENTS, ALL FROM THE SAME HOSPITAL.

    Description of Event or Problem · 1

    A NURSE REPORTED THERE WAS AN EXTERNAL LEAK FROM THE BOTTOM OF THE PRISMASATE BAG CAUSING THE MACHINE TO POWER OFF DURING PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669620 PRISMASATE DIALYSATE CONCENTRATE FOR HEMODIALYSIS(LIQUID OR POWDER) KPO GAMBRO DASCO SPA 762733

    Patients

    Seq Age Sex Outcome Treatment
    1 Other