BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPATH PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2316578 · Received October 6, 2011

    Report

    Report Number
    1219343-2011-00226
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    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

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2010 TO REPORT AN ORTHOPAT MACHINE BLOOD SPILL AND MACHINE WAS SMOKING. NO PT INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED. ON (B)(4) 2011 DEVICE WAS EVALUATED AND INTERNAL FLUID SPILL CONFIRMED. BLOOD ALSO FOUND ON CENTRIFUGE MOUNT AND INTERNAL SURFACES OF TOP DECK AND CHASSIS. ELECTRONIC COMPONENTS REQUIRED REPLACEMENT. 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). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2010 TO REPORT AN ORTHOPAT MACHINE BLOOD SPILL AND MACHINE WAS SMOKING. NO PT INJURY WAS REPORTED. NO OPERATOR INJURY 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