BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2822780 · Received November 2, 2012

    Report

    Report Number
    1219343-2012-00169
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    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

    THE DEVICE WAS ORIGINALLY RETURNED TO HAEMONETICS AS A SWAP OUT AND NOT DUE TO ANY SPECIFIC COMPLAINT. THE DEVICE WAS EVALUATED ON (B)(4) 2012 AND IT DETERMINED AT THAT TIME THAT A HIGHER LEVEL REVIEW NEEDED TO BE DONE. THERE WAS FLUID INGRESS FOUND AND ELECTRICAL COMPONENTS DAMAGED. THE ELECTRICAL COMPONENTS REPLACED BECAUSE OF THE SPILL INCLUDE: DISTRIBUTION PCBA, CENTRIFUGE, AND COMPRESSOR. THE SOFTWARE WAS NOTED TO BE THE CORRECT VERSION. A ROUTINE CLEANING AND UPGRADE OF OTHER ELECTRICAL COMPONENT NOT DAMAGED WAS DONE. THE DEVICE WAS RETURNED TO SERVICE. (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A REQUEST TO SWAP ORTHOPAT DEVICES AND THE DEVICE WAS RETURNED TO HAEMONETICS ON (B)(4) 2012. UPON INSPECTION OF THE DEVICE IT WAS NOTED THAT ELECTRICAL COMPONENTS WERE DAMAGED DUE TO A FLUID SPILL. NO PT/OPERATOR INJURY ASSOCIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1