BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2083503 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05699
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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 REPORTED ISSUE OF THE FIRST FILL (ON THE HOMECHOICE DEVICE) COMING FROM THE SUPPLY BAG FIRST WAS CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. A SERVICE HISTORY REVIEW REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM OF DELIVERING SOLUTION FROM THE SUPPLY BAG. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE SUFFICIENT. THE CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING FURTHER FOLLOW UP WITH THE NURSE REGARDING THE DELIVERY STATUS OF THE HOMECHOICE (HC) DEVICE, THE NURSE CLARIFIED THAT THE HC DEVICE WAS NEVER RETURNED TO BAXTER. PER THE NURSE, THE DEVICE WAS SIMPLY PICKED-UP FROM THE HP AND BROUGHT TO THE CLINIC WHERE IT WAS CHECKED OUT AND NO ISSUES WERE FOUND. PER NURSE, THE HP WAS PROVIDED WITH ANOTHER HC CYCLER FROM THE CLINIC. THE NURSE STATED THAT HP IS DOING FINE AND CONTINUING THERAPY. NO FURTHER INFORMATION WAS PROVIDED. THE HC DEVICE WAS NOT RETURNED TO BAXTER; THEREFORE, NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE FLUID CAME FROM THE SUPPLY BAG FIRST WHILE ON THE HOMECHOICE (HC) SYSTEM THE NIGHT BEFORE DURING FILL 1. THE HOME PATIENT (HP) STATED THAT WHEN HE FELT THE COLD SOLUTION GOING IN, HE "CRAMPED-UP" FOR A MINUTE, THEN PUT THE SUPPLY BAG ON TOP OF THE HEATER AND FINISHED OUT HIS THERAPY. THE HP TO WATCH THAT NIGHT AND CALL IF THERE IS A PROBLEM. 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 REPORTED PROBLEM, IT WAS REVEALED THAT THEIR MACHINE HAD BEEN SWITCHED OUT SINCE THEN DUE TO THE PROBLEM. THE HP STATED THAT THEIR OLD MACHINE WAS PULLING THE SOLUTION FROM THE COLD BAG FIRST. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. DURING FURTHER FOLLOW UP WITH THE NURSE ON (B)(6) 2011 REGARDING THE HP GETTING A SWAP OF THE HC MACHINE, IT WAS CONFIRMED THAT THE HP HAD RECEIVED ANOTHER HC MACHINE FROM BAXTER ON (B)(6) 2011. MOREOVER, THE NURSE STATED THAT THE MACHINE HAD BEEN EVALUATED AND THEY COULD NOT FIND ANYTHING WRONG WITH THE MACHINE. THE NURSE DID STATE THAT THE HP HAD BEEN CHECKED UP AND THE HP WAS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    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 53 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE