BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241976 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12013
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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 LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR SYSTEM ERROR (SE) 2240 WAS CONFIRMED. AS PER THE COMPLAINT, THE PATIENT HAD A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY. THE ASSIGNABLE CAUSE WAS DETERMINED TO USE ERROR- OPEN CLAMP. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) REGARDING A SYSTEM ERROR 2240. PER THE PDRN, THE NURSE THAT WAS WITH THE HOME PATIENT (HP) AT THE TIME OF THIS EVENT IS NO LONGER WITH THEM. THE PDRN IS NOT AWARE OF ANY PROBLEMS WITH THIS HP AND STATED THE HP HAS BEEN DOING WELL ON THERAPY. NO FURTHER INFORMATION COULD BE OBTAINED AT THIS TIME. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER TO REPORT HAVING A SYSTEM ERROR 2240 ALARM WITH THE HOMECHOICE (HC) MACHINE DURING DWELL 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ALARM AND INFORMED THE HP OF THE ALARM'S MEANING. THE HP WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. 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 60 YR HOMECHOICE