BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2890990 · Received December 20, 2012

    Report

    Report Number
    1219343-2012-00187
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K992723
    Removal / Correction Number
    1219343-04/29/2011-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EVIDENCE OF FLUID INGRESS WAS FOUND. THE FUSE WAS BLACKENED AND THE DEVICE WOULD NOT POWER ON. THE FOLLOWING CRITICAL ELECTRICAL COMPONENTS WERE REPLACED: TOP DECK DISTRIBUTION BOARD CENTRIFUGE, CABLE DRIVER/DISTRIBUTION, POWER SUPPLY, AC LINE FILTER, DRIVER BOARD AND COMPRESSOR. THE DEVICE WAS CLEANED, REPAIRED AND UPGRADED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2012, TO REPORT AN ORTHOPAT DEVICE WITH DESCRIPTION "FLUID SPILL, TECH DID NOT INSTALL BIOHAZARD BAG CORRECTLY. SMELLED SMOKE COMING FROM MACHINE." NO PATIENT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1