BEUDAMED
    FDA Adverse Event Other Summary report: N

    XTRA EQUIPMENT 110V, 60HZ

    MDR report key: 5060881 · Received September 3, 2015

    Report

    Report Number
    9611109-2015-00346
    Event Type
    Other
    Date Received
    September 3, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 10, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    CAC
    PMA / PMN Number
    K131553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "DATE OF EVENT" ON INITIAL REPORT SHOULD HAVE BEEN (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE XTRA EQUIPMENT. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP. SORIN GROUP RECEIVED A REPORT THAT SAMPLES TAKEN FROM BLOOD PROCESSED USING AN XTRA AUTOTRANSFUSION DEVICE SHOWED HEMOLYSIS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION BUT THERE WAS NO INJURY. A REPORT AGAINST THE DISPOSABLE WAS FILED UNDER MEDWATCH NUMBER 9680841-2015-00413. THE DEVICE WAS NOT RETURNED TO SORIN GROUP FOR INVESTIGATION, BUT AN INVESTIGATION WAS PERFORMED BY THE CUSTOMER. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER HAS REVEALED THAT THE REPORTED ISSUE WAS UNRELATED TO THE XTRA AUTOTRANSFUSION DEVICE AND THE DISPOSABLE. A PATHOLOGIST ANALYZED THE CELL SAVOR BLOOD AND WAS ABLE TO RULE OUT ANY ISSUES WITH THE BLOOD. AFTER A FULL INVESTIGATION, THE FACILITY CONCLUDED THAT THE ISSUE EXPERIENCED BY THE PATIENT WAS NOT RELATED TO CELL SALVAGE. THE PATIENT WAS ON ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS AT THE TIME OF THE EVENT, WHICH ARE WIDELY USED AS TREATMENT FOR HYPERTENSION. HYPOTENSION IS A POTENTIAL SIDE EFFECT OF THE USE OF THESE DRUGS. NO FURTHER INVESTIGATION IS REQUIRED AS THERE IS NO INDICATION THAT THIS ISSUE WAS RELATED TO CELL SALVAGE. A REVIEW OF THE DHR WAS UNABLE TO IDENTIFY ANY CONCESSIONS, DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED FAILURE. NO TREND WAS IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE XTRA EQUIPMENT. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT SAMPLES TAKEN FROM BLOOD PROCESSED USING AN XTRA AUTOTRANSFUSION DEVICES SHOWED HEMOLYSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION BUT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586697 XTRA EQUIPMENT 110V, 60HZ APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP DEUTSCHLAND 75221 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP