BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI SET

    MDR report key: 2040345 · Received February 15, 2011

    Report

    Report Number
    8030665-2011-00009
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 3, 2011
    Report Date
    March 15, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT (03-2622-3) LOT (10NR01218) WAS REVIEWED AND THE FOLLOWING HIGHLIGHTS WERE FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY DOCUMENTED NCR'S OR REPROCESS OR DEVIATION ASSOCIATED WITH THE COMPLAINT. ALL THE APPLICABLE IN-PROCESS AND FINAL INSPECTION TESTS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND WERE DOCUMENTED WITH ACCEPTABLE RESULTS. THE LOT NUMBERS OF THE TUBES WERE INVESTIGATED TO CONFIRM IF THE COMPONENT INVOLVED IN THE ASSEMBLY OF THIS PRODUCT HAD A NON CONFORMANCE REPORT (NCR). THE RESULTS WERE NEGATIVE. SAMPLE ANALYSIS: THE ACTUAL BLOODLINE WAS RECEIVED FOR EVALUATION. DURING VISUAL ANALYSIS OF THE ACTUAL SAMPLE, IT WAS CONFIRMED A CUT ON THE ARTERIAL TUBING WHICH WAS IDENTIFIED BETWEEN THE MAIN LINE TUBING TO THE BOTTOM OF THE VENOUS CHAMBER. DURING THE INVESTIGATION, THE POSSIBLE CAUSES FOR THE DEFECT WERE IDENTIFIED. CORRECTIVE ACTION: BASED ON THE DATA OBTAINED FROM THE INVESTIGATION, THERE IS NO INDICATION THAT THIS DEFECT OCCURRED DURING THE MANUFACTURING OF THE DEVICE. A DUE DILIGENCE WAS PERFORMED IN THE MANUFACTURING PROCESS AND OPPORTUNITIES OF IMPROVEMENT WERE FOUND, CHANGES ARE DOCUMENTED THROUGH WORK ORDER FORM (RPEM-006-01). THIS IMPROVEMENT WAS PERFORMED ON (B)(6) 2010. THIS LOT WAS MANUFACTURED PRIOR TO THE IMPROVEMENT. MANUFACTURING PERSONNEL WERE INFORMED INCLUDING PICTURES. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED. (B)(6) NA WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A HEMODIALYSIS USER FACILITY WHO HAS REPORTED THE FOLLOWING INCIDENT: A PATIENT HAD STARTED DIALYSIS WHEN BLOOD WAS NOTICED TO BE SQUIRTING FROM BOTH VENOUS AND ARTERIAL LINES. THE RN CLAMPED THE LINE. THE EBL WAS 600CC. THE FACILITY HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION. IT HAS BEEN LEARNED ON (B)(6) 2011 IN SPEAKING WITH THE REPORTER, THAT THE PATIENT IS FINE AND THAT NO MEDICAL INTERVENTION HAS RESULTED. THE NURSE REPORTED THAT THEY DID NOT SEE THE LEAK DURING PRIME; HOWEVER, WHEN THE DIALYSIS TREATMENT WAS STARTED, THEY NOTICED THE BLOOD LOSS. A NEW SET WAS USED TO COMPLETE THE TREATMENT. A STAT H AND H WAS DRAWN AND CONFIRMED THAT THE RESULTS WERE WITHIN NORMAL LIMITS. THE PATIENT DID NOT REQUIRE ANY MEDICAL TREATMENT. A NEW SET OF HEMODIALYSIS BLOODLINES WERE USED TO COMPLETE THE TREATMENT AS PRESCRIBED WITHOUT FURTHER INCIDENT. THE PATIENT WAS DISCHARGED TO HOME WHEN THE TREATMENT WAS COMPLETE. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI SET HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 10NR01218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA