BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 3001713 · Received March 11, 2013

    Report

    Report Number
    1219343-2013-00023
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THERE WAS FLUID INGRESS FOUND INTERNAL TO THE DEVICE. BLOOD WAS FOUND ON THE POWER SUPPLY ASSEMBLY AND IT WAS REPLACED. THE DEVICE WAS CLEANED AND RETURNED TO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACT HAEMONETICS ON (B)(6) 2013 TO REPORT AN ORTHOPAT DEVICE WITH THE DESCRIPTION OF "POWER FAILURE - ELECTRICAL PROBLEM / SHORT CIRCUIT." NO PT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101779 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1