BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2230379 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11512
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR AIR IN TUBING (WITHOUT ALARM) WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE WAS NOT DETERMINED. ACCORDING TO THE NURSE, THE PATIENT FALSIFIED THE COMPLAINT DUE TO A MEDICAL CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    DURING ASSISTANCE WITH AIR IN THE LINE ON THE HOME CHOICE (HC), DURING USE; THE HOME PATIENT (HP) CLAIMED THAT SOMEONE HAD BROKEN INTO THEIR HOME AND SWITCHED OUT THE HC WITH A DIFFERENT HC WITH THE SAME SERIAL NUMBER. THE HP CLAIMED THIS ROBBER HAD ALLEGEDLY CHANGED THE PROGRAMMING AND THE TEMPERATURE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TOLD THE HP TO DISCARD THE SUPPLIES AND CONTACT THEIR NURSE, ALONG WITH CONTACTING THE POLICE FOR THE HOME INVASION. DURING A FOLLOW-UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) REGARDING THE REPORTED PROBLEM, THEY STATED THE PATIENT WAS A PSYCHIATRIC PATIENT. THE PD RN STATED THAT THE PATIENT RECENTLY HAD A CHANGE OF MEDICATION, OR WERE OFF THEIR MEDICATION. THE PD RN STATED THEY WERE WORKING ON STABILIZING THE PATIENT BY ADJUSTING THEIR MEDICATION. THE PD RN STATED THE HC WAS NOT SWAPPED BY A ROBBER, THE PROGRAMMING WAS NOT CHANGED, AND THE FLUID TEMPERATURE WAS NOT CHANGED EITHER. THE PD RN STATED THEY DID DECREASE THE FLUID TEMPERATURE BY ONE DEGREE TO FIT THE COMFORTS OF THE PATIENT. THE PD RN STATED THE HP NEVER CONNECTED FOR THERAPY OR INITIATE THERAPY FOR THAT EVENING, SO THE AIR IN LINE WAS NOT AN ISSUE. 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 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR