BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2974040 · Received February 19, 2013

    Report

    Report Number
    1219343-2013-00016
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HAMEMONETICS 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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE REPORTED ISSUE WAS CONFIRMED AND UPON FURTHER INVESTIGATION FLUID INGRESS WAS NOTED INSIDE THE DEVICE. DAMAGED WAS DONE TO KEY ELECTRICAL COMPONENTS. THE FOLLOWING PARTS WERE REPLACED DUE TO THE FLUID INGRESS: POWER SUPPLY, TOP DECK DISTRIBUTION BOARD, AND INTERNAL DRAIN TUB. THE DEVICE WAS CLEANED AND UPGRADED TO THE CURRENT FLUID REMEDIATION REVISION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2012 TO REPORT AN ORTHOPAT DEVICE WITH THE DESCRIPTION OF "DISK LOAD ERROR." NO PT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72437 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAMEMONETICS CORP

    Patients

    Seq Age Sex Outcome Treatment
    1