BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2329307 · Received October 24, 2011

    Report

    Report Number
    1219343-2011-00376
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    February 24, 2009
    Report Date
    February 24, 2009
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS RECEIVED AN ORTHOPAT MACHINE 02/24/2009 FOR SERVICE. NO INJURY OR REACTION NOTED. UPON EVAL OF THE DEVICE A BLOOD SPILL WAS FOUND. ALL CONTAMINATED AND DAMAGED COMPONENTS WERE REPLACED. THE MACHINE IS NOW READY FOR USE. THIS REPORT REFLECTS A PRODUCT ISSUE IDENTIFIED DURING A RETROSPECTIVE REVIEW OF SERVICE RECORDS. NO PT OR USER HARM OR INJURY WAS REPORTED OR ALLEGEDLY ASSOCIATED WITH THE ISSUE IDENTIFIED IN THE SERVICE RECORD. ACTIONS TAKEN IN RESPONSE TO THIS ISSUE ARE RECORDED IN HAEMONETICS' CAPA RECORD (B)(4). THESE ACTIONS HAVE BEEN COMMUNICATED TO THE FDA AND UNDER 21 USC 360I(F). HAEMONETICS (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED AN ORTHOPAT MACHINE 02/24/2009 FOR SERVICE. NO INJURY OR REACTION NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1