BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1811574 · Received August 23, 2010

    Report

    Report Number
    1423500-2010-02781
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SE 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOTS (H10D23069) WITH NO ISSUES NOTED. 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 6/7. THE HOME PATIENT (HP) WAS CONNECTED AND HAD ALREADY CLEARED THE ALARMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND THE POSSIBLE CAUSES TO THE HP. THE HP THEN REVEALED THAT THE SUPPLY BAGS WERE SUCKED DRY WHEN ALARM OCCURRED. THE HP WOULD CALL THE NURSE REGARDING AIR DETECT ALARM AND BEING CONNECTED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP, THE HP EXPLAINED THAT HE HAD CHECKED THE WHOLE SETUP THOROUGHLY, BUT WAS UNABLE TO FIND THE CAUSE OF THE ALARM. PER HP, THERE WERE NO DEFECTS ON THE SUPPLIES. THE HP STATED THAT HE HAD NOTIFIED THE NURSE, AND CONFIRMED THAT HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT HE 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 AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) INFUSOR TWO DAY DEVICE HAD RUPTURED DURING FILLING. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL (5-FU). THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL 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 H10D23069

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR