BEUDAMED
    FDA Adverse Event Other Summary report: N

    COD.740E/125 WASH SET X ELECTA

    MDR report key: 1855216 · Received September 30, 2010

    Report

    Report Number
    1718850-2010-00154
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    July 23, 2010
    Report Date
    September 30, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE ELECTA WASH SET. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). IT WAS REPORTED THAT DURING AN ATS PROCESSING PROCEDURE, BLOOD LEAKED FROM THE REINFUSION BAG. BLOOD LOSS WAS APPROXIMATELY 10 CC. THE ELECTA REINFUSION BAG WAS NOT RETURNED TO SORIN GROUP (B)(4) FOR EVAL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO PROBLEMS OR DEVIATIONS. SORIN GROUP (B)(4) STATED THAT THE LEAK MAY HAVE BEEN CAUSED BY INSUFFICIENT SOLVENT APPLICATION AT THE TUBING TO LUER CONNECTION DURING ASSEMBLY. THE THERMAL STRESSES OF STERILIZATION MAY HAVE WEAKEN THE BOND AND CAUSED THE LEAK TO OCCUR DURING USE. SINCE THE PRODUCT WAS NOT RETURNED, THIS COULD NOT BE CONFIRMED. NO FURTHER ACTION IS DEEMED NECESSARY. THERE WAS NO PT INJURY. THE HOSPITAL REPORTED THE INCIDENT TO THE (B)(4). THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATS PROCESSING PROCEDURE, BLOOD LEAKED FROM THE REINFUSION BAG. BLOOD LOSS WAS APPROXIMATELY 10 CC. THIS WAS AN AUTOLOGOUS BLOOD PROCESSING PROCEDURE. THE PT WAS NOT DIRECTLY IMPACTED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COD.740E/125 WASH SET X ELECTA ELECTA WASH SET CAC SORIN GROUP ITALIA NA 1002040071

    Patients

    Seq Age Sex Outcome Treatment
    1 NP