BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALOMAR MED CTR ESCONDIDO CA 1

    MDR report key: 4102741 · Received September 11, 2014

    Report

    Report Number
    1718850-2014-00337
    Event Type
    Other
    Date Received
    September 11, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 12, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT A STOP COCK CHANGED DIRECTION DURING A PROCEDURE RESULTING IN BLOOD LOSS. THE PATIENT WAS DISCHARGED WITH NO INJURY. IT WAS ALSO REPORTED THAT BLOOD PRODUCTS WERE ADMINISTRATED TO COMPENSATE FOR THE BLOOD LOSS. THE MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. NO PRODUCT WAS RETURNED FOR EVALUATION. ONE RETAIN SAMPLE FROM THE INVOLVED LOT WAS PULLED FOR EVALUATION. INSPECTION OF THE RETAIN SAMPLE FOUND NO DEFECTS OR ANORMALITIES AND THE FORCE REQUIRED TO CHANGE THE DIRECTION OF FLOW WAS FOUND TO BE COMPARABLE TO CONTROL UNITS FROM CURRENT INVENTORY. THE RETAINED SAMPLE WAS THEN SUBJECTED TO STIMULATED USE TESTING BASED ON A DESCRIPTION ON HOW THE DEVICE WAS BEING USED AT THE TIME OF THE INCIDENT FOR APPROXIMATELY 6 HOURS IN AN ATTEMPT TO REPRODUCE THE REPORTED ISSUE. THE SAMPLE WAS ABLE TO COMPLETE THIS TEST WITH NO SIGNS OF A CHANGE IN THE DIRECTION OF FLOW. THE REPORTED ISSUE COULD NOT BE REPRODUCED. COMMUNICATION WITH THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL REVEALED THAT THEIR INTERNAL INVESTIGATION DETERMINED THE ISSUE WAS CAUSED BY USER ERROR AND NO PROBLEM WITH ANY SORIN PRODUCT WAS IDENTIFIED. AT THE REQUEST OF RISK MANAGEMENT THE PERFUSION GROUP HAS CHANGED THEIR SETUP TO PREVENT FUTURE OCCURRENCES. SINCE NO EVIDENCE WAS FOUND TO SUGGEST THAT THE ISSUE WAS CAUSED BY A DEFECT OR MALFUNCTION OF ANY SORIN GROUP WILL CONTINUE TO MONITOR THE MARKET FOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT A STOP COCK CHANGED DIRECTION DURING A PROCEDURE RESULTING IN BLOOD LOSS. IT WAS ALSO REPORTED THAT BLOOD PRODUCTS WERE ADMINISTERED TO COMPENSATE FOR THE BLOOD LOSS. THE PATIENT WAS DISCHARGED WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563242 PALOMAR MED CTR ESCONDIDO CA 1 CUSTOM PERFUSION PAK DTZ SORIN GROUP USA, INC. NA 1409300061

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Other