BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141651 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08401
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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 IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE CAUSE FOR THE REPORTED ISSUE WAS AIR IN THE LINE. 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 RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A LOW DRAIN VOLUME ALARM (LDV) WHICH OCCURRED ON HOME CHOICE (HC) DURING INITIAL DRAIN. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CHECK LINE FOR KINKS, OCCLUSIONS, AIR BUBBLES AND FIBRIN. THE HP STATED THAT THERE WERE GAPS OF AIR IN PATIENT LINE. THE TSR ADVISED THE HP TO CHECK LINE BEFORE CONNECTING. THE TSR ASSISTED THE HP IN ENDING THERAPY ON THE HC. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS WRITER CONTACTED HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP STATED THEY DID HAVE TO START OVER WITH NEW SUPPLIES. THE HP STATED THAT THEY NOTICED THAT THE PATIENT LINE EXTENSION HAD AIR THE LINE. THE HP STATED THAT THEY BELIEVE IT MIGHT HAVE BEEN DUE TO THEM NOT CHECKING THE SETUP ALL THE WAY, BUT THEY ARE NOT SURE. THEY STATED THEY DID NOT TALK TO THEIR REGISTERED NURSE (RN) REGARDING THE ALARM NOR THE AIR. THE HP STATED THEY HAVE BEEN CONTINUING THERAPY WITHOUT FURTHER PROBLEMS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 76 YR HOMECHOICE