BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS SET

    MDR report key: 2623088 · Received June 14, 2012

    Report

    Report Number
    1722028-2012-00359
    Event Type
    Other
    Date Received
    June 14, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 18, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD WAS REVIEWED. NOTHING WAS FOUND THAT WAS RELATED TO THIS EVENT. ROOT CAUSE: BASED ON THE EVALUATION OF THE SET, THERE WAS A LEAK PATH ON THE BOND BETWEEN THE SAMPLE BULB AND THE SAMPLE TUBING. IT WAS NOT POSSIBLE TO DETERMINE IF THE LEAK PATH WAS CAUSED BY A MANUFACTURING ERROR OF INSUFFICIENT SOLVENT OR DUE TO THE HANDLING ISSUE REPORTED BY THE CUSTOMER. CORRECTIVE ACTION: ASSEMBLER RETRAINING WAS PERFORMED AS A CORRECTION TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. BOTH PLATELET BAGS WERE RECEIVED, REGARDING THE COLLECTION FOR THIS EVENT. UPON INSPECTION OF THE SAMPLE BULB LINE IT WAS NOTICED THAT THERE WAS A LEAK COMING FROM THE BOND OF THE SAMPLE LINE TO THE BOND. AFTER FURTHER INSPECTION A LEAK PATH WAS NOTICED IN THE BOND CONNECTION OF THE SAMPLE BULB TO THE SAMPLE LINE. SQUEEZED THE SAMPLE BULB AND PLATELETS LEAKED OUT OF THE LINE AROUND THE AREA OF THE LEAK PATH. ROOT CAUSE IS LIKELY DUE TO INSUFFICIENT SOLVENT APPLIED. HOWEVER, IF THE OPERATOR STRIPPED THE SAMPLE LINE WITH THE SLIDE CLAMP THEN IT IS POSSIBLE TO CREATE A LEAK PATH WITH IMPROPER STRIPPING TECHNIQUES. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED FOR THIS ISSUE. IT WAS LATER REPORTED BY THE CUSTOMER THAT NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER RELEASE, THERE WAS A LEAK AT THE PRODUCT SAMPLER. THE CUSTOMER MENTIONED ADDITIONAL MEDICAL INTERVENTION, BUT IT IS UNKNOWN AT THIS TIME WHAT THAT MEDICAL INTERVENTION WAS. TERUMO BCT IS AWAITING THE RETURN OF THE DISPOSABLE SET FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS SET AUTOMATED BLOOD CELL SEPARATOR LKN TERUMO BCT 03U2201

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR