BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1974282 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01311
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    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; THE REPORTED CONDITION WAS RESOLVED OVER THE PHONE AND THERAPY CONTINUED WITH ACTUAL PRODUCT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A CHECK LINES AND BAGS ALARM. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. PER THE COMPLAINT INFORMATION, THE SPIKE WAS NOT FULLY INSERTED INTO THE SOLUTION BAG. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE ALARM IS IMPROPER SETUP OF THE SUPPLY BAG. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE REPORTED USER ERROR 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 IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOMECHOICE (HC) DURING PRIME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING. THE HP STATED HE PRESSED IN ON THE SPIKE TO HEATER BAG AND THERAPY RESUMED. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT THIS WAS AN ISOLATED INCIDENT AND WAS HIS ERROR. THE HP STATED HE WAS HALF ASLEEP AND DID NOT PUSH THE SPIKE IN ALL THE WAY INITIALLY. THE HP STATED THAT HE WAS AWARE OF PROPER PROCEDURE AND CONFIRMED NO ADVERSE EVENT RESULTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE APD SSYTEM (B)(4) REFURBISHED