BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1841799 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03633
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 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). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 1 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AN OPEN CLAMP ON UNUSED SUPPLY LINE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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 TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 1 ON THE HOMECHOICE. THE HP REPORTED THERE WAS AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP RECYCLE POWER EXPLAINED THE THERAPY HAS ENDED AND WILL NEED TO START OVER WITH NEW SUPPLIES OR DO MANUAL EXCHANGE. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL AND TOLD HP TO CONTACT PERITONEAL DIALYSIS (PD) REGISTERED NURSE AND INFORM OF SE 2240. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS NURSE REPORT FROM (B)(4) OF TOUCH CONTAMINATION AND BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER (B)(4), THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENTS. ON AN UNREPORTED DATE IN 2010, DIANEAL THERAPY WAS WITHDRAWN. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION RESOLVED. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH (B)(6) WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND DIANEAL PD4 AMBUFLEX THERAPY.

    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 71 YR