BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2923848 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01481
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE ISSUE IS CONFIRMED BECAUSE IT WAS REPORTED THAT PATIENT PUT TAPE AROUND THE HOLE AND CONTINUE USING THE SET AFTER PIERCING THE PATIENT LINE BY A STEP STOOL WHICH CAUSED A FLUID LEAK. THE ASSIGNABLE CAUSE IS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER TO REPORT AN ALARM AND DURING THE CONVERSATION THE CUSTOMER REPORT A USE ERROR OCCURRED. THE HOME PATIENT (HP) STATED THAT HE WAS USING A STEP STOOL TO GET INTO BED AND IT PINCHED THE PATIENT LINE WHICH CAUSED A HOLE IN THE TUBING THAT RESULTED IN A LEAK. THE HP CLOSED THE PATIENT LINE AND ATTEMPTED TO PUT TAPE AROUND THE HOLE AND CONTINUED USING THE SET. THE DRAIN VOLUME EQUALED -14MLS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT HE WOULD NEED TO END THERAPY AND ADVISED THE PATIENT TO CONTACT HIS REGISTERED NURSE ABOUT THE HOLE IN THE LINE. THE TSR ASSISTED WITH ENDING THERAPY. THE HP WOULD COMPLETE THERAPY MANUALLY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2013. HE STATED THAT THE PATIENT HAD SPOKEN WITH HIM ABOUT THIS INCIDENT. THE PATIENT WAS PREVENTATIVELY ADMINISTERED ANTIBIOTICS. THE NURSE WAS MONITORING THE PATIENT'S AFFLUENT, AND SO FAR IT HAS BEEN CLEAR. THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31021 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE