BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2242304 · Received September 10, 2011

    Report

    Report Number
    1423500-2011-12033
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 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 DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED DUE TO LACK OF SAMPLE THEREFORE THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A CHECK PATIENT LINE ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE THEN REOPEN TRANSFER SET, REMOVE TAPE FROM THE PATIENT LINE AND PULL UP ON LINES NEAR DOOR. THE HP STATED THAT THE PATIENT LINE CONTAINED LARGE GAPS OF AIR. THE BAXTER TSR ASSISTED CAREGIVER (CG) WITH ENDING THERAPY AND ADVISED USE OF NEW DISPOSABLES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION BUT THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2011 REGARDING THE CHECK PATIENT LINE ALARM. THE HP REPORTED THAT THE ISSUE WAS RESOLVED BY STARTING OVER WITH NEW SUPPLIES. THE HP SAID THAT SHE IS NEW TO PD THERAPY AND WHEN SHE REPORTED THIS INCIDENT TO THE NURSE THAT SHE BELIEVED IT WAS DUE TO THE CATHETER NOT BEING FLUSHED AND AIR WAS STILL IN HP'S SYSTEM WHEN THE CATHETER WAS PUT IN. PER HP, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP STATED THAT SHE DISCUSSED THE ALARM WITH THEIR NURSE. PER HP, SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 62 YR HOMECHOICE