BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A-V COMBISET 24/CS

    MDR report key: 294179 · Received August 31, 2000

    Report

    Report Number
    8030665-2000-00264
    Event Type
    Injury
    Date Received
    August 31, 2000
    Date of Event
    August 9, 2000
    Report Date
    August 31, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE CLINIC REPORTING TWO SIMILAR OCCURRENCES WITH ONE LOT NUMBER. THE PRODUCT NUMBER IS 03-2432-7. APPARENTLY "THE SALINE PORT SNAPPED OFF DURING USE". "QS" CALLED FACILITY TO FIND OUT IF "USE" MEANING DURING PRIMING OR DURING PT USE. RN ADVISED "QS" TO CALL BACK LATER WHEN SHE IS AVAILABLE TO RESPOND. RN DID CONFIRM THAT COMPLAINT SAMPLES ARE AVAILABLE FOR ANALYSIS. EVENT TYPE TO BE DETERMINED WITH MORE INFO REC'D. 8/15/00: FURTHER INFO REC'D FROM CUSTOMER. FIRST EVENT TOOK PLACE AT THE END OF PT TREATMENT WITH REINFUSION. THE SALINE TEE SEPARATED FROM THE MAIN LINE TUBING AS NURSE WAS MOVING CLAMP POSITIONS. THERE WAS AN ESTIMATED BLOOD LOSS OF 200CC DUE TO DISCARD OF EXTRACORPOREAL CIRCUIT; ACTUAL BLOOD LOSS 10-20CC FROM LEAK. THE PT EXPERIENCED NO ADVERSE EFFECTS. NORMAL SALINE WAS GIVEN TO THE PT. MDR FILED ON BLOOD LOSS GREATER THAN 20 CC. "QS" INFORMED THAT PREVIOUSLY SAVED COMPLAINT SAMPLE WAS INADVERTANTLY DISCARDED AT FACILITY. REQUESTED COMPANION SAMPLES. THIS IS THE FIRST OF TWO RELATED EVENTS, ONE WITH PT USE, ONE AFTER PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-V COMBISET 24/CS HEMODIALYSIS BLOODLINE FJK ERIKA DE REYNOSA 03-2432-7 OER011

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R