BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2182149 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09882
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 2011
    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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DWELL WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE PATIENT REPORTED THAT THE ISSUE WAS RESOLVED AND THAT HE DISCUSSED THE ALARM WITH HIS NURSE. THE PATIENT STATED THAT THE REPORTED INFECTION WAS PERITONITIS. THE PATIENT ALSO STATED THAT HE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE BAXTER DIALYSIS PRODUCTS. THE PATIENT STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THIS OCCURRENCE OF PERITONITIS WAS REPORTED ON INITIAL MEDWATCH REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE ALL THE CLAMPS AND THE TRANSFER SET, AND CYCLE THE POWER OFF AND ON; A SE 2367 OCCURRED. THE TSR HAD THE HP CYCLE THE POWER OFF AND ON AGAIN TO THE PRESS GO TO START PROMPT. THE TSR EXPLAINED THE ALARMS AND THE CAREGIVER (CG) STATED THEY WERE UNSURE WHY THE HP GOT SE 2240 ALARMS; THERE WERE NO LEAKS. THE HP DID NOT DISCONNECT DURING THERAPY. THERE WERE NO WET LINES AND THE SPARE LINE CLAMP WAS CLOSED. THE TSR EXPLAINED THE CG SHOULD DISCARD ALL THE SUPPLIES AND REPORT THE ALARMS TO THE PERITONEAL DIALYSIS NURSE THE NEXT MORNING. THE HP WOULD FINISH THAT NIGHT'S THERAPY MANUALLY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS 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 - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR DIANEAL PD-2, SINGLE BAG DEXTROSE 1.50%| HOME CHOICE