BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL SAVER ELITE

    MDR report key: 4307428 · Received December 4, 2014

    Report

    Report Number
    1219343-2014-00027
    Event Type
    Death
    Date Received
    December 4, 2014
    Date of Event
    November 2, 2014
    Report Date
    November 6, 2014
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K120586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HAEMONETICS PRODUCT SUPPORT RECEIVED A CALL ON (B)(6) 2014 FROM A CUSTOMER STATING THAT WHILE THEY WERE UTILIZING THE CELL SAVER ELITE DEVICE, THEY RECEIVED ERROR CODE (LINE SENSOR NOT DETECTING FLUID WHEN EXPECTED), AND THAT CLEANING THE LINE SENSOR DID NOT RESOLVE THE ISSUE. THE CUSTOMER LATER CALLED BACK ON (B)(6) 2014 AND INDICATED A PT DEATH WAS INVOLVED IN A CASE ON (B)(6) 2014 AND DURING THE INCIDENT CALLER INDICATED THE OPERATOR COULD NOT GET THE SHED BLOOD TO PROCESS AND SOME CLOTS WERE SEEN IN THE RESERVOIR. AN EVENT CODE, FLUID NOT DETECTED WHEN EXPECTED, PRECEDED THE LINE SENSOR EVENT CODE. THE CUSTOMER HAD CALLED IN A PREVIOUS COMPLAINT ON THE SAME DEVICE ON (B)(6) 2014 FOR THE ISSUE OF A POWER SUPPLY FAILURE. THE DEVICE WAS STILL IN USE. A HAEMONETICS FIELD SERVICE ENGINEER EVALUATED THE DEVICE ON (B)(6) 2014. THERE WAS NO PROBLEM FOUND. A FUNCTIONAL TEST WAS RUN WITH NO ISSUES AND THE DEVICE MET MFR SPECIFICATIONS. THE DRIVER PCB WAS REPLACED AS A PRECAUTION TO ADDRESS THE REPORTED POWER SUPPLY ISSUE FROM (B)(6) 2014. THE DEVICE WAS PUT BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782826 CELL SAVER ELITE CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death