BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1904738 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05952
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 24, 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). THIS COMPLAINT IS FOR A REPORT OF ONE OF THE SUPPLY BAGS DISCONNECTING. IN A FOLLOW UP CALL BY PRODUCT SURVEILLANCE, THE PATIENT STATED THE SUPPLY BAG LOST BALANCE AND FELL OFF THE TABLE CAUSING THE SPIKE TO DISCONNECT FROM THE BAG. THE PATIENT STATED THAT HE DISCUSSED THE ISSUE WITH THE NURSE, AND HAS ADJUSTED THE WAY HE SETS-UP THE BAG ON THE TABLE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SEPARATION IS DUE TO ONE OF THE SUPPLY BAGS FALLING AND DISCONNECTING. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. 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. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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 INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE SUPPLY BAG BECAME DISCONNECTED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 1 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH END OF THERAPY EARLY PROCEDURE. THE HP STATED THAT HE WOULD NOTIFY THE PERITONEAL DIALYSIS NURSE AND COMPLETE THERAPY VIA MANUAL SUPPLIES. DURING A FOLLOW UP WITH THE HP REGARDING THE CONNECTION ISSUE, THE HP EXPLAINED THAT THE BAG LOST BALANCE AND FELL OFF THE TABLE CAUSING THE SPIKE TO DISCONNECT FROM THE BAG. THE HP STATED THAT HE DISCUSSED THE ISSUE WITH THE NURSE, AND HAS ADJUSTED THE WAY HE SETS UP THE BAG ON THE TABLE. THE HP STATED THAT THE ISSUE WAS RESOLVED AND HE IS DOING FINE AND CONTINUING THERAPY WITHOUT FURTHER ISSUES. THE HP CONFIRMED THAT 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 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR