BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2133933 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07845
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS NOT RETURNED FOR EVALUATION, SO THE ISSUE COULD NOT BE CONFIRMED AND A CAUSE COULD NOT BE DETERMINED. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT WITH REGARDS TO SETTING THE INITIAL DRAIN VOLUME ALARM. 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). THE FOLLOWING INFORMATION WAS MISSED IN THE INITIAL EMDR.PER THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) CALLSRIPT, THE REPORTER (CLINICAL EDUCATOR) HAD ALSO MENTIONED THAT PATIENT HAD SYMPTOMS OF ABDOMINAL PAIN OR DISCOMFORT. HOWEVER, THE PATIENT DID NOT HAVE SYMPTOMS AT THE TIME OF THE CALL. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE CLINICAL EDUCATOR (CE) WANTED TO KNOW IF THE HOME PATIENT (HP) DID A MANUAL EXCHANGE DURING THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED WOULD NOT KNOW IF THE HP DID A MANUAL EXCHANGE ON THE HC. THE TSR REVIEWED THE PROGRAMMING: FILL VOLUME 2000ML. THE TSR REVIEWED THE THERAPY LOG: CYCLE 1 UF 2395ML, 0 BYPASSES, 0 MANUAL DRAIN, NO THERAPY CHANGE. THE RN DRAINED BEFORE STARTING THE MANUAL EXCHANGE AND LEFT 2000ML IN THE HP BEFORE STARTING THERAPY. THE TSR EXPLAINED THE INITIAL DRAIN ALARM SETTING. THE TSR OFFERED TO SWAP, BUT THE RN DECLINED. THERE WAS PATIENT INVOLVEMENT, BUT 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1