BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2031926 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03742
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF AIR IS AN ALLEGATION AGAINST THE CASSETTE; HOWEVER, SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING. THE HP STATED SHE COULD FIND NO REASON FOR THE ALARM AS ALL PARTS OF THE SET UP LOOKED FINE. THE TSR EXPLAINED THE SE 2240 ALARM INDICATES AIR ENTERED THE SET UP. THE TSR FURTHER ADVISED THE HP TO ALERT HER NURSE ABOUT THE ALARM SINCE SHE WAS CONNECTED. THE TSR ASSISTED THE HP TO CLEAR THE ALARM. THE HP STILL WANTED TO DO A FILL AND DID NOT HAVE MANUAL BAGS. THE TSR THEN ASSISTED THE HP TO START OVER WITH NEW SUPPLIES. THE HP CONFIRMED TO COMPLETE THE I-DRAIN AND STATED SHE WOULD DO ONE CYCLE WITH A PURPLE BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE