BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM

    MDR report key: 12864693 · Received November 23, 2021

    Report

    Report Number
    1219343-2021-00146
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 4, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    UDI-DI
    10812747016537
    PMA / PMN Number
    K120586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 4, 2021 HAEMONETICS MANUFACTURING PERFORMED A VISUAL INSPECTION OF THE RECEIVED BOWL FROM THE CELL SAVER® ELITE SET - 125ML AND CONFIRMED BLOOD IN THE INNER CORE WITH A CRACK IN THE INNER CORE BASE. ALTHOUGH THERE WAS NO SERIOUS INJURY OR HARM, PAST REPORTING (1219343-2020-00001-01) INDICATES THIS PARTICULAR MALFUNCTION ON A SIMILAR DEVICE HAS BEEN ASSOCIATED WITH A REPORTED DEATH EVENT. THE INVESTIGATION OF 1219343-2020-00001-01 INDICATED THE INNER CORE OF THE BOWL MALFUNCTIONED VIA A CRACK BUT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT ACCORDING TO THE SURGEON THAT PERFORMED THE SURGERY. HAEMONETICS DECIDED TO CONSERVATIVELY REPORT INNER CORE CRACKS THAT ARE CONFIRMED BY MANUFACTURING DUE THE EVENT OF THE PAST REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF BLOOD GOING INTO THE WASTE BAG DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761879 CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM CELL SAVER ELITE SET - 125ML CAC HAEMONETICS CORPORATION CSE-P-125-JA 0521020 10812747016537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown