BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2062662 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04686
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 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). THE SAMPLE NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CARE GIVER (CG) STATED THAT THE SUPPLY BAG FELL AND BECAME DISCONNECTED CAUSING THE ERROR. THE HP'S WIFE STATED THAT THE SUPPLY FELL AND DISCONNECTED BECAUSE THE CASSETTE LINE CAME OUT IF THE SUPPLY BAG; SHE DIDN'T TIGHTEN THE CONNECTION ENOUGH. 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. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL 2/5 WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING DWELL 2 OF 5. THE CARE GIVER (CG) STATED THAT THE SUPPLY BAG FELL AND BECAME DISCONNECTED CAUSING THE ALARM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED THE CG TO END THERAPY. THE CG WILL NOTIFY THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) AS SOON AS POSSIBLE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER SPOKE WITH THE HP'S WIFE (B)(6) ON (B)(4) 2011 REGARDING THE REPORTED PROBLEM. SHE STATED THAT THE SUPPLY FELL AND DISCONNECTED BECAUSE THE CASSETTE LINE CAME OUT IF THE SUPPLY BAG; SHE DIDN'T TIGHTEN THE CONNECTION ENOUGH. SHE STATED THAT IT WAS HER FAULT AND SHE HAS INFORMED THE NURSE OF WHAT HAPPENED. SHE STATED THAT SHE KNOWS TO CHECK THE CONNECTION BETWEEN THE BAGS AND LINES TO AVOID THE SAME PROBLEM FOR OCCURRING. SHE STATED THAT NOTHING UNUSUAL WAS NOTICED WITH THE CASSETTE TUBING OR BAGS AND DID NOT HAVE ANY PRODUCT INFORMATION AVAILABLE. SHE STATED THE HP IS DOING FINE AND RESUMING WITH THERAPY ON THE CYCLER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR