BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AV LOOP KIT

    MDR report key: 3050644 · Received March 14, 2013

    Report

    Report Number
    1319030-2013-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    August 3, 2011
    Report Date
    March 13, 2013
    Manufacturer
    TRANSONIC SYSTEMS, INC.
    Product Code
    DXG
    PMA / PMN Number
    K080116
    Removal / Correction Number
    1319030-2013-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REVIEW OF THIS COMPLAINT WAS DEEMED NOT TO BE REPORTABLE DUE TO NO ADVERSE EVENT TAKING PLACE. DURING ROUTINE INSPECTION NOW TAKING PLACE AT THE MANUFACTURER'S FACILITY, THE FDA INVESTIGATOR RECOMMENDED THAT A MEDWATCH REPORT BE FILED FOR THIS COMPLAINT. NO PATIENT IDENTIFIER INFORMATION IS AVAILABLE DUE TO THE DATE THE INITIAL COMPLAINT WAS RECEIVED AND THE HOSPITAL DID NOT DOCUMENT ANY INFORMATION REGARDING THE EVENT. AN ADDITIONAL QUALITY TEST HAS SINCE BEEN INSTITUTED TO 100% INSPECT THE CASSETTE THAT FAILED UNDER EXCESS PRESSURE TO ALLEVIATE THIS KIND OF PROBLEM.

    Description of Event or Problem · 1

    BLOOD LEAKED INTO CASSETTE. THIS WAS A NEW AV LOOP AND THE RESEARCHER FOUND THE CASSETTE BLOODY AND THERE WAS BLOOD ON THE PUMP AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108463 AV LOOP KIT TRANSONIC COSTATUS SYSTEM DXG TRANSONIC SYSTEMS, INC. HCS3011 010311

    Patients

    Seq Age Sex Outcome Treatment
    1