BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 1850683 · Received October 1, 2010

    Report

    Report Number
    1423500-2010-04014
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE AT THIS TIME. 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). THIS COMPLAINT IS FOR A CHECK PATIENT LINE ALARM AND AIR IN THE PATIENT LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE WAS NOT IDENTIFIED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR OF HP DISCONNECTING AND THEN RECONNECTING AFTER AIR WAS FOUND IN THE LINE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE WAS A HOLE IN THE PATIENT'S TRANSFER SET ALLOWING AIR INTO THE PATIENT LINE AND TRIGGERING A CHECK PATIENT LINE ALARM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP WITH THE HEAD NURSE, THE NURSE STATED THAT SHE HAD SOME BASIC INFORMATION ONLY. THE HEAD NURSE STATED THAT THE HOME PATIENT (HP) HAD A PIN HOLE SIZE HOLE IN HIS TRANSFER SET SO THE TRANSFER SET WAS CHANGED OUT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE HOME PATIENT (HP) WITH TROUBLESHOOTING THE ALARM. THE HP THEN REVEALED THAT THE PATIENT LINE HAD ABOUT A FOOT OF AIR, AND THAT HE CHECKED AFTER PRIMING. THE TSR ADVISED THE HP TO SET UP WITH NEW SUPPLIES, BUT THE HP DECLINED. THE HP STATED THAT HE WAS GOING TO DISCONNECT AND LET IT PUSH SOLUTION IN THE PATIENT LINE THEN CLEAN PATIENT LINE AND QUICKLY RECONNECT. THE TSR ADVISED HP NOT TO DO THAT, AND TO SET UP WITH NEW SUPPLIES. THE HP DISCONNECTED AND PRESSED GO. THE TSR ENDED THE PHONE CALL. THE TSR THEN FOLLOWED-UP WITH THE NURSE AND EXPLAINED HOW HP HAD DISCONNECTED AND RECONNECTED TO GET AIR OUT OF PATIENT LINE. THE NURSE SAID THAT SHE WOULD FOLLOW-UP WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR