BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 1943275 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07485
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A DEVICE HISTORY REVIEW WILL NOT BE CONDUCTED. 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). ADDITIONAL INFORMATION: THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED; HOWEVER, THE ALARM WAS DETERMINED TO BE CAUSED BY A USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION FOR THE LOW DRAIN VOLUME ALARMS IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT HAS BEEN UPDATED TO THE APPROPRIATE PRODUCT INVOLVED.ADDITIONALLY, THE SAMPLE IS BEING NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A LOW DRAIN VOLUME ALARM THAT APPEARED ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN, THE HOME PATIENT (HP) REVEALED THAT HE DRAINED INTO A CAN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED HP IF DRAIN LINE WAS IN THE BOTTOM OF CAN, AND THE HP STATED YES. THE TSR ASSISTED THE HP WITH TROUBLESHOOTING AND WITH RESUMING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP REGARDING THE USE ERROR, IT WAS REVEALED THAT THE ISSUE HAD BEEN RESOLVED AND THAT HE IS CONTINUING THERAPY ON THE HC CYCLER WITHOUT ANY FURTHER ISSUES. THE HP CONFIRMED THAT HE DISCUSSED THE ISSUE WITH HIS NURSE AS WELL. PER HP, HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 HOMECHOICE CYCLER| APD SET WITH CASSETTE