BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2101249 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06429
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 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). 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 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. AS PER THE COMPLAINT INFORMATION, THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. THE CAREGIVER STATED THAT HE FORGOT TO CLOSE THE UNUSED LINE CLAMPS. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 (TSR) TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING INITIAL DRAIN. THE CARE GIVER (CG) HAD FORGOTTEN TO CLOSE CLAMPS ON THE UNUSED LINE. THE TSR HAD THE CG TO CYCLE THE POWER ON HC AND SE 2367 DISPLAYED. THE HC PROCEEDED TO "PRESS GO TO START." THE CG STATED THAT THE HOME PATIENT (HP) WILL START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(4) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE NURSE REGARDING THE SE 2240 ALARM. THE NURSE STATED THAT THE PATIENT HAD VISITED THEM ON (B)(6) 2011 AND THE PATIENT IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUE. THE PATIENT HAD NOT MENTIONED THE ALARM. THE NURSE STATED THAT THE PATIENT IS VERY SHARP AND DILIGENT ON FOLLOWING PROPER PROCEDURES.

    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 74 YR HOMECHOICE PRO