BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1850678 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-04008
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED, AND THE LOT NUMBER WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SE 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 1. THE HOME PATIENT (HP) STATED THAT ALL THE LINES WERE CONNECTED AND THAT HE DID NOT DISCONNECT FROM TUBING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP AND ASSISTED TO TROUBLESHOOT THE ALARM. THE HP TO RESTART WITH NEW SUPPLIES AND NOTIFY THE PERITONEAL DIALYSIS NURSE. DURING A FOLLOW UP WITH THE NURSE REGARDING THE ALARM, THE NURSE VERIFIED THAT SHE HAD DISCUSSED WITH THE HP ABOUT THE ALARM, AND FURTHER ADDED THAT THE ISSUE WAS RESOLVED. PER NURSE, CAUSE WAS UNKNOWN. THE NURSE STATED THAT HP DID NOT REPORT ANY LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER NURSE, HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE NURSE STATED THAT THE HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT OBTAIN ANY BENEFIT FROM HIS IMPLANT, BUT HE SUFFERED FROM FACIAL NERVE STIMULATION. AT IMPLANTATION THE ELECTRODE WAS NOT COMPLETELY INSERTED INTO THE COCHLEA. A CT SCAN CARRIED OUT IN (B)(6) 2010 SHOWED A FOLDOVER OUTSIDE THE COCHLEOSTOMY. THE PATIENT WAS RE-IMPLANTED ON (B)(6), 2010 WITH ANOTHER MANUFACTURER'S DEVICE.

    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 62 YR