BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPEATIVE AUTOTANSFUSION SYSTEM

    MDR report key: 2961578 · Received February 11, 2013

    Report

    Report Number
    1219343-2013-00011
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE REPORT OF FLUID SPILL WAS CONFIRMED. THERE WAS FLUID IN THE DRAIN TUBES AND ON THE CHASSIS. THERE WAS ALSO WHITE CONTAMINANT ON THE POWER SUPPLY WHICH WAS BLOWN. THE POWER SUPPLY WAS REPLACED AND THE DEVICE UPGRADED TO THE CURRENT FLUID INGRESS REVISION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2013 TO REPORT AN ORTHOPAT DEVICE WITH THE DESCRIPTION OF "FLUID SPILL." NO PATIENT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60041 ORTHOPAT PERIOPEATIVE AUTOTANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1