BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 14789684 · Received June 23, 2022

    Report

    Report Number
    2032582-2022-00003
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 23, 2022
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE DEVICE HISTORY RECORD WAS PERFORMED AND NO DEVIATIONS WERE FOUND. NO NON-CONFORMANCE RECORD ASSOCIATED WITH LOT#141399 THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. REVIEW OF RECORDED COMPLAINTS ON THE LAST THREE YEARS (2019-2022): NO COMPLAINT RECORDED FOR LOT#141399. NO SIMILAR ISSUE IDENTIFIED ON DUAL PORT. (B)(4. REVIEW OF RISK ANALYSIS: RISK IS IDENTIFIED WITHIN THE RISK ANALYSIS. POTENTIAL OCCURRENCE'S RATE OF (B)(4). OCCURRENCE'S RATE IS BELOW ACCEPTABLE FREQUENCY OF THE RISK ANALYSIS. RETURN PRODUCT INVESTIGATION: 1 PORT HAVE BEEN RECEIVED IN A BIO-HAZARD PACKAGING. NO EXTERNAL PRODUCT PACKAGING OR LABEL WERE AVAILABLE. A VISUAL INSPECTION HAS BEEN PERFORMED. IT CLEARLY APPEARS THAT ONE OF THE TWO CHANNELS OF THE CATHETER HAS "BURST'' AT ABOUT 2CM FROM THE CLICK END. FUNCTIONAL TESTING VERIFICATION: A FLUSHING TEST HAS BEEN PERFORMED WITH WATER ON EACH CHAMBER OF THE PORT. CHAMBER 1 (WITH THE "T" AT THE BACK) IS BLOCKED. CHAMBER 2 (WITH THE "C" AT THE BACK), SIDE OF THE "BURSTED" CATHETER HAS BEEN RINSED EASILY WITHOUT APPLYING EXCESSIVE PRESSURE AND WATER CAME OUT THROUGH BOTH END OF CATHETER END BURST. POTENTIAL ROOT CAUSES: LACK OF RINSING OR ERROR IN RINSING PROCEDURE FOR THE PORT BLOCKAGE CAUSING BLOOD CLOT PINCH-OFF CAUSING CATHETER RUPTURE DUE TO IMPLANTATION TOO CLOSE OF CLAVICLE TOO HIGH PRESSURE INJECTION CAUSING BURST CHANNEL CONNECTED TO CHAMBER 2, ESPECIALLY IF USED DESPITE BLOOD CLOT CONCLUSION: DEVICE HISTORY RECORDS REVIEW DEMONSTRATES THAT PRODUCT MEETS ITS SPECIFICATIONS. THE INVESTIGATION OF THE RETURN PRODUCT PORT CONCLUDES THAT THE PORT IS OBSTRUCTED BY BLOOD RESIDUES AND THAT THE CATHETER BURST AT ABOUT 2 CM IF THE PIN. THE RISK IS IDENTIFIED IN OUR RISK ANALYSIS AND OCCURRENCE RATE AND SIMILAR COMPLAINTS REVIEW IS BELOW THE THRESHOLD FREQUENCY OF THE RISK ANALYSIS.

    Description of Event or Problem · 0

    PORT WAS PLACED IN FOUR YEARS AGO FROM CATH LAB VASCULAR SURGERY FROM ANOTHER FACILITY. LAST APPOINTMENT WITH INFUSION NURSES, THEY WERE UNABLE TO DRAW BLOOD AND INSTEAD SAW SOME SWELLING IN THE AREA. PORT REMOVED IN THE OUTPATIENT SETTING NOTING IT WAS BROKEN (CUT) ABOUT AN INCH FROM THE PORT. DEVICE INFORMATION FROM THE CHART: PORT POWER INJECTABLE XCELA DUAL LUMEN PLASTIC 9.6 PRE-ATTAC PORT POWER INJECTABLE XCELA DUAL LUMEN PLASTIC 9.6 PRE-ATTAC NAVILYST_MEDICAL_INC. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BLOOD DRAW. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692006 XCELA PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT PFM MEDICAL CPP SA H965451840 141399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention