BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPATH PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2359570 · Received November 8, 2011

    Report

    Report Number
    1219343-2011-00401
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Date of Event
    April 2, 2009
    Report Date
    April 2, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2009, HAEMONETICS RECEIVED A LOANER ORTHOPAT MACHINE FOR REPAIR. NO INJURY OR REACTION WAS REPORTED. UPON EVAL OF THE DEVICE A BLOOD SPILL WAS FOUND INSIDE OF THE WALL VACUUM VALVE. THE HEADER ARM WAS ALSO OUT OF ALIGNMENT. THE MACHINE WAS DECONTAMINATED AND ALL COMPONENTS WHICH WERE DAMAGED 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).

    Description of Event or Problem · 1

    ON (B)(6) 2009, HAEMONETICS RECEIVED A LOANER ORTHOPAT MACHINE FOR REPAIR. NO INJURY OR REACTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1