BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243297 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12053
    Event Type
    Malfunction
    Date Received
    September 12, 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 SAMPLE WAS NOT RETURNED, SO NO EVALUATION COULD BE PERFORMED AND NOT BATCH REVIEW WAS DONE SINCE THE LOT NUMBER WAS UNKNOWN. 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).

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM WHICH OCCURRED ON THE HOMECHOICE DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) CHECK THE LINE FOR KINKS, OCCLUSIONS, FIBRIN AND AIR BUBBLES. THE CG STATED THAT THERE WERE GAPS OF AIR IN PATIENT LINE. THE INITIAL DRAIN VOLUME EQUALED 10ML. THE TSR ADVISED THE CG TO CHECK THE PATIENT LINE FOR AIR BUBBLES BEFORE THE HOME PATIENT (HP) CONNECTS. THE TSR ASSISTED CG IN ENDING THE THERAPY. THE TSR ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION, BUT THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE CHECK PATIENT LINE ALARM. THE HP REPORTED THAT THE ISSUE WAS RESOLVED, BUT HE DID NOT KNOW WHAT CAUSED THE AIR IN THE LINE. THE HP SAID THAT HE PRIMES THE LINE BEFORE CONNECTING. PER HP, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT HE 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 72 YR HOMECHOICE