BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1823929 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03121
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FROM A LEAK WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT SHE DISCOVERED A PUDDLE OF SOLUTION ON THE FLOOR AND COULD NOT FIND WHERE IT CAME FROM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH ENDING THERAPY AND STARTING OVER WITH NEW DISPOSABLES. THE HP TO START OVER WITH NEW DISPOSABLES. DURING A FOLLOW UP WITH THE NURSE REGARDING THE PUDDLE OF SOLUTION ON THE FLOOR, THE NURSE STATED THAT SHE HAD SPOKEN TO THE HP EARLIER THAT DAY. THE NURSE DID NOT KNOW THE SOURCE OF THE PUDDLE OF SOLUTION. PER NURSE, HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE NURSE STATED THAT HP DID NOT REPORT ANY LOOSE CONNECTION, SEPARATIONS OR DEFECTS ON ANY OF THE SUPPLIES. PER NURSE, HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUE. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR THORACIC AORTIC ANEURYSM IN ZONES 3 AND 4 APPROX 83 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED 24 MONTHS POST STENT GRAFT IMPLANT THE PT HAD A TYPE III ENDOLEAK, SEPARATION RESULTING IN A CONTAINED RUPTURED ANEURYSM, AND WAS REPAIRED WITH ANOTHER MANUFACTURER¿S DEVICE. IT WAS REPORTED THAT THE SUBJECT RECENTLY HAD A CT SCAN WHICH REVEALED INTERVAL ENLARGEMENT OF THE TAA SECONDARY TO DEVICE FAILURE AS THERE IS A TOTAL POSTERIOR FRACTURE OF THE THORACIC STENT GRAFT. AT THIS TIME THE PHYSICIAN WILL MONITOR THE PT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. (2953200-2010-02315, 2953200-2010-02317).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG THE HOME PATIENT (HP) FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10E27109

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR