BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1802035 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02562
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF AIR IN THE PATIENT LINE. THE REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED UPON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CLINIC'S SURGICAL SERVICE BUYER (SSB) CONTACTED BAXTER TO REPORT THAT WITHIN THE LAST MONTH OR SO, A SURGEON HAD BEEN HAVING PROBLEMS WITH AN UNSPECIFIED AMOUNT (POSSIBLY 4-5) TRANSFER SETS IN CONJUNCTION WITH THE ADAPTER. THE SURGEON WAS REPORTEDLY UNABLE TO TWIST ON TO THE TRANSFER SET; THE CLAMP TURNED ONLY AN 8TH OF A TURN AND HE FELT LIKE IT SHOULD TWIST ON FURTHER. OVERALL THE SURGEON WAS REPORTEDLY DISSATISFIED WITH THE LOCKING MECHANISM OF THE PRODUCT. THE PROBLEM TOOK PLACE DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. DURING A FOLLOW UP WITH THE SSB REGARDING THE REPORTED ISSUE, IT WAS EXPLAINED THAT A SURGEON COMPLAINED ABOUT HAVING DIFFICULTY DURING SURGERY TO CONNECT THE TRANSFER SET TO THE PLASTIC ADAPTER (BRAND: KENDALL/COVIDIEN). THE SURGEON FIRST HAND-TIGHTENS AND BECAUSE HE WOULD FEEL UNSURE AS IT DOES NOT TIGHTEN ALL THE WAY, THE SURGEON WOULD RESORT TO USING A CLAMP TO GIVE IT ANOTHER TWIST. THE SSB COULD NOT CONFIRM IF 4 OR 5 EVENTS WERE REPORTED. PER SSB, THE SURGEON DID NOT REPORT ANY LEAKS, LOOSE CONNECTIONS, DISCONNECTIONS, PATIENT INJURIES OR MEDICAL OR INTERVENTIONS.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REQUESTING HELP TO RE-PRIME THE PATIENT LINE DURING SET-UP. THE HP STATED AFTER SHE CONNECTED SHE NOTICED A LOT OF AIR IN THE PATIENT LINE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASSISTED THE HP TO DISCONNECT HERSELF AND START OVER WITH ALL NEW SUPPLIES. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP'S NURSE WHO STATED THAT SHE WAS NOT AWARE OF THIS INCIDENT; HOWEVER, HAD BEEN IN CONTACT WITH THE HP SINCE THIS REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THIS EVENT WAS AN ISOLATED INCIDENT. SHE HAS HAD NO FURTHER ISSUES WITH HER SET UP OR PRIMING. THE HP STATED SHE WAS CONFIDENT WITH HER TECHNIQUE AND CHECKS SET UP CAREFULLY BEFORE CONNECTING. THE HP REPORTED NO ADVERSE EVENTS. THE HP CONFIRMED SHE IS DOING FINE WITH HER THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR