BEUDAMED
    FDA Adverse Event Other Summary report: N

    APPARATUS, AUTOTRANSFUSION

    MDR report key: 5074994 · Received September 9, 2015

    Report

    Report Number
    9680841-2015-00345
    Event Type
    Other
    Date Received
    September 9, 2015
    Date of Event
    August 14, 2015
    Report Date
    February 28, 2017
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K101586
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE XTRA AUTOTRANSFUSION PROCEDURE SET. THE INCIDENT OCCURRED IN EL (B)(6). (B)(4). THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE INVOLVED DEVICE TO SORIN GROUP (B)(4) FOR INVESTIGATION. ANALYSIS OF THE PHOTO CONFIRMED A LEAK FROM A RUPTURE IN THE PUMP LOOP OF THE XTRA SET. BASED ON SIMILAR CASES INVESTIGATED IN THE PAST, THE ISSUE WAS LIKELY CAUSED EITHER BY AN INCORRECT LENGTH OF THE PUMP LOOP OR BY AN INCORRECT AUTOMATIC LOADING OF THE PUMP LOOP INTO THE XTRA EQUIPMENT. AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ORIGIN OF THE RUPTURE. AS THE LOT OF THE XTRA SET WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS THE DEFECT RATE FOR THIS TYPE OF ISSUE IS REMOTE, NO CORRECTIVE ACTION IS NECESSARY. HOWEVER, SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. THE LOT NUMBER WAS NOT PROVIDED. THE EXPIRATION DATE UNK. THE INFO WILL BE FORWARDED WHEN AVAILABLE. MFG DATE. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE THE MANUFACTURING DATE IS UNK. IT WILL BE FORWARDED WHEN AVAILABLE. SORIN GROUP (B)(4) MANUFACTURES THE XTRA AUTOTRANSFUSION PROCEDURE SET. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT PUMP BOOT OF THE AUTOTRANSFUSION SET LEAKED DURING THE PROCEDURE. NO MEDICAL INTERVENTION OR BLOOD PRODUCTS WERE GIVEN AS RESULT OF THE LEAK. THERE WAS NO REPORT OF PT INJURY. 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 THE PUMP BOOT OF THE AUTOTRANSFUSION SET LEAKED DURING THE PROCEDURE. NO MEDICAL INTERVENTION OR BLOOD PRODUCTS WERE GIVEN AS A RESULT OF THE LEAK. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594929 APPARATUS, AUTOTRANSFUSION XTRA AUTOTRANSFUSION SYSTEM CAC SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP