BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3183402 · Received June 22, 2013

    Report

    Report Number
    1722028-2013-01261
    Date Received
    June 22, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION SHOWED BLOOD IN THE SET. NO KINKS, OCCLUSIONS OR MIS-ASSEMBLIES WERE NOTED. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. UPON FURTHER INVESTIGATION OF THE RETURNED SET, IT WAS NOTED THAT THE METAL DISC WAS COMING AWAY (DECOUPLED) FROM THE DIAPHRAGM OF THE ACCESS PRESSURE SENSOR (APS).ROOT CAUSE: A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THE RESULTS FROM OUR ONGOING INVESTIGATION SUGGEST THAT THIS ISSUE IS MOST LIKELY CAUSED BY (BUT NOT LIMITED TO) THE FOLLOWING:-AN ISSUE WITH THE DIAPHRAGM/DISC ADHESIVE-MANUFACTURING PROCESS RESIDUAL ON THE DIAPHRAGM AND/OR DISC-INSUFFICIENT DIAPHRAGM SURFACE TREATMENT-VENDOR COMPONENT MANUFACTURING PROCESS ISSUE-SUBASSEMBLY MANUFACTURING PROCESS ISSUE CORRECTION: TERUMO BCT IS CURRENTLY INVESTIGATING INTERNAL PROCESSES IN ADDITION TO WORKING WITH THE VENDOR OF THESE COMPONENTS TO EVALUATE POTENTIAL WAYS TO REDUCE THE LIKELIHOOD OF THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AT THE BEGINNING OF THE PROCEDURE, THEY RECEIVED AN ALARM, 'PRESSURESENSOR FAILURE' THEY STOPPED THE DONATION,AND PER THE CUSTOMER IT WAS IMPOSSIBLE TO RETURN THE CONTENT OF THE CHANNEL TO THE PATIENT. THE PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. TERUMO BCT IS AWAITING THE RETURN OF THE DISPOSABLE SET. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Description of Event or Problem · 1

    THE DONOR IS UNDER SPECIAL MONITORING SINCE THE DONATION.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER. THERE ARE NO CHANGES IN THE PATIENT'S CONDITION TO REPORT AS A RESULT OF THE PATIENT'S SPECIAL MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284333 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC , PAS, TLR SET GKT TERUMO BCT 02V3215

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR