BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR HARD SHELL 20 CELL SAVER

    MDR report key: 21560324 · Received March 10, 2025

    Report

    Report Number
    MW5167450
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 4, 2025
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CELL SAVER MADE NOISE DURING PROCEDURE AND AFTER FURTHER INVESTIGATION, THE BOWL IN THE CELL SAVER WAS CRACKED. THIS PREVENTED THE SURGEON FROM USING THE CELL SAVER. ON (B)(6) 2025, 73 YO FEMALE, RIGHT TOTAL HIP ARTHROPLASTY ANTERIOR APPROACH PMH = ARRHYTHMIA, ARTHRITIS, DIABETES MELLITUS, DISEASE OF THYROID GLAND. THE SMALL BOWLS WITH THEIR SPECIFIC DEFECT, WILL CRACK IN ANY OF THE CELL SAVERS - RESERVOIR HARD SHELL 20 CELL SAVER 00220-00 NO HARM TO PATIENT, REPORTED TO MANUFACTURER (HAEMONETICS CORPORATION) - SERIAL NUMBER (B)(6) LAST IN-SERVICE DATE = (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339629 RESERVOIR HARD SHELL 20 CELL SAVER APPARATUS, AUTOTRANSFUSION CAC HAEMONETICS CORPORATION 00220-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown