BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SAVER ELITE

    MDR report key: 2833489 · Received October 30, 2012

    Report

    Report Number
    1219343-2012-00168
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K120586
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER EVALUATED THE DEVICE. A DATA DOWNLOAD WAS PRINTED WITH NO ERRORS NOTED DURING THE PROCEDURE. THE DISPOSABLE UNIT HAS BEEN RETURNED, BUT CONTAMINATION HAS DELAYED EVAL. THE HOSP CONDUCTED ALL TESTING ON THE PT'S BLOOD, URINE AND BLOOD FROM THE REINFUSION BAG. (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON (B)(6) 2012 FOR A CELL SAVER ELITE DEVICE WITH THE DESCRIPTION "LEAKING IN TUBING FROM CSE-P-125 SET. BLOOD OUTSIDE CLOSED CIRCUIT OF THE SET WHICH HAS BEEN REINFUSED TO PT". A UROLOGICAL SURGERY WAS CONDUCTED USING A CELL SAVER ELITE DEVICE. THE COLLECTED RBC PRODUCT WAS REINFUSED TO THE PT. DURING THE REINFUSION, A LEAK WAS NOTED ON THE TUBING OF THE DISPOSABLE KIT. TESTING WAS DONE ON THE BLOOD THAT LEAKED ONTO THE DEVICE, WHICH SHOWED (B)(6). THIS BACTERIUM IS FOUND NATURALLY ON THE SKIN'S SURFACE, THEREFORE IF THE DEVICE WAS IN CONTACT WITH HUMAN SKIN IT CAN BE TRANSFERRED TO THE DEVICE. TESTING WAS ALSO DONE ON THE RE-INFUSION BAG. THE RESULTS WERE POSITIVE FOR (B)(6). IT IS UNK WHETHER OR NOT THIS CAME FROM THE SURGICAL FIELD DURING CELL COLLECTION. TWO DAYS AFTER THE PROCEDURE, (B)(6) 2012, TWO BLOOD SAMPLES WERE TAKEN FROM THE PT. THESE WERE BOTH NEGATIVE FOR ANY BACTERIAL GROWTH. ON (B)(6) 2012, SAMPLES WERE TESTED FROM THE PT'S URINE. THIS SAMPLE WAS POSITIVE FOR (B)(6). HOWEVER, THE PT HAD BEEN GIVEN AN INDWELLING CATHETER DURING THE HOSPITALIZATION. IT IS NOT POSITIVELY CONFIRMED THAT THE BACTERIA WAS CAUSED BY THE TRANSFUSED CELLS OR BY A URINARY TRACT INFECTION CAUSED BY THE CATHETER. THE PT WAS THEN GIVEN AN ANTIBIOTIC, COTRIMOXAZOL (BACTRIMEL), FOR THIS INFECTION. DUE TO THIS REASONING, IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THIS INFECTION. THERE IS POTENTIAL FOR HARM CAUSED BY THE LEAK IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL SAVER ELITE CAC HAEMONETICS CORP. M11100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention