BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2153727 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08786
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, 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). THIS COMPLAINT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED IN THE LAB. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE FOR AN AIR BUBBLES IN PATIENT LINE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. THE CAUSE WAS UNDETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    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 INITIAL DRAIN. THE DRAIN VOLUME EQUALED 22ML. THE HP STATED THAT THERE WERE A LOT OF AIR BUBBLES IN HIS PATIENT LINE AND HE NEEDED TO START OVER WITH ALL NEW SUPPLIES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) THEN ASSISTED THE HP TO CYCLE POWER OFF/ON, END THE THERAPY AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF MEDICAL INTERVENTION OR PATIENT INJURY. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE CHECK PATIENT LINE ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED BY ENDING THERAPY AND CONTACTING THE NURSE IN THE MORNING. THE HP DID ONE MANUAL BAG IN THE MORNING AND CONTINUED THERAPY AS USUAL IN THE EVENING. HOWEVER, THE CAUSE OF THE ALARM AND THE AIR IN THE TUBING REMAINED UNKNOWN. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, HE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION 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 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 51 YR HOMECHOICE