BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2121158 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07505
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE SUPPLY BAG CAME DISCONNECTED FROM THE SUPPLY LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DWELL 3 OF 5. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HELPED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND INFORMED THE MEANING OF THE ALARM. THE HP WILL RESTART WITH NEW SETUP. THE TSR DOCUMENTED DURING TROUBLESHOOTING THAT THE BAG WAS DISCONNECTED DURING THERAPY. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER CONTACTED CARE GIVER (CG) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE CARE GIVER (CG) STATED THAT THIS WAS THE SECOND TIME THIS ALARM HAS OCCURRED. THEY STATED THEY CALLED BOTH TIMES INTO THE TECHNICAL SERVICES FOR ASSISTANCE. THE CG STATED THEY DID TALK TO THEIR DOCTOR REGARDING THE ALARM, AND THINGS WERE IRONED OUT. THE CG STATED THAT THEY ARE NOT SURE WHAT CAUSED THE ALARM. THEY THINK IT MIGHT BE RELATED TO THEIR PRESCRIPTION CHANGE OR MAYBE POSSIBLY RELATED TO THE SOLUTION BAG NOT FLOWING. THE CG AND THE HP DID NOT RECALL THE LOT NUMBERS TO THE SUPPLIES. THEY STATED THEY DO NOT HAVE SAMPLES AVAILABLE. THE CG STATED THERAPY HAS BEEN GOING BETTER THEN IT WAS BEFORE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICEPRO