BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL SAVER 5 AUTOLOGOUS RECOVERY SYSTEM

    MDR report key: 10198045 · Received June 25, 2020

    Report

    Report Number
    1219343-2020-00053
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    May 27, 2020
    Report Date
    May 27, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    UDI-DI
    10812747016131
    PMA / PMN Number
    K014083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED AT THIS TIME. A PHOTO WAS PROVIDED OF THE BOWL FROM THE CELL SAVER® 5 SET WHICH ONE COULD OBSERVE THAT A LEAK HAS OCCURRED. THE BOWL HAS YET TO BE RETURNED AND EVALUATED BY HAEMONETICS. WITHOUT PHYSICAL SAMPLE PROVIDED FOR EVALUATION THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON MAY 27 2020 HAEMONETICS WAS NOTIFIED OF AN ADVERSE EVENT WHICH OCCURRED ON THE 1ST CYCLE OF THE PROCESS PHASE DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. A TOTAL OF 800ML OF BLOOD WAS LOST, PROCEDURE WAS STOPPED IMMEDIATELY AND ALLOGENEIC BLOOD WAS TRANSFERRED TO PATIENT. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657384 CELL SAVER 5 AUTOLOGOUS RECOVERY SYSTEM CELL SAVER 5/5+ BOWL KIT-225ML CAC HAEMONETICS CORPORATION 00263-00 0719076 10812747016131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other