BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1920358 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06775
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE REPORT, THE PATIENT HAD THE LINE GET CAUGHT ON THE WALL AND THE SPIKE PULLED OUT OF THE BAG. THIS REPORT FOR A CONNECTION ISSUE - DISCONNECTION FROM A SUPPLY BAG WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. PER THE COMPLAINT INFORMATION THE CAUSE OF THE COMPLAINT IS USE ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) PROBLEM OF A CAREGIVER (CG) THAT STATED THAT SHE NEEDED ASSISTANCE ENDING THERAPY BECAUSE A BAG BECAME DISCONNECTED, THIS PROBLEM OCCURRED DURING DWELL 1 OF 9. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THE CAREGIVER (CG) STATED THAT THE HP HIT ONE OF THE BAGS AND IT BECAME DISCONNECTED. THE CG STATED THAT THE HC WAS IN DWELL. THE TSR HAD THE CG CYCLE THE POWER. THE CG STATED THAT THE HC READ CONFIRM CARD SO THE CG STATED THAT THE HC HAD BEEN DISPLAYING CONFIRM CARD SINCE THE DOCTORS THE OTHER DAY. THE TSR ASSISTED THE CG WITH CONFIRMING THE PROCARD. THE CG STATED THAT THE HC READ PROGRAM ACCEPTED. THE HC ALARMED POWER RESTORED DURING DWELL 1 OF 9. THE TSR HAD THE CG CLOSE THE CLAMPS AND DISCONNECT THE HP. THE TSR ASSISTED THE CG WITH ENDING THE THERAPY AND GETTING THE SET OUT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE WAS CONTACTED BY THE CAREGIVER ON (B)(6) 2010. THE CAREGIVER STATED THE FOLLOWING: THE PATIENT HAD THE LINE GET CAUGHT ON THE WALL AND THE SPIKE PULLED OUT OF THE BAG WHEN THE LINE WAS CAUGHT. A NEW SETUP WAS USED TO CLEAR THE ALARM AND THERAPY WAS GOING WELL. THE PATIENT WAS HAVING PROBLEMS WITH LOW DRAINS AND CALLS IN TO THE TECHNICAL SERVICE TO GET A BYPASS. BAXTER ADVISED SHE CONTACT THE NURSE REGARDING BOTH EVENTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 H10H27053

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR PD CYCLER