BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2182291 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09884
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 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 DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING FILL 2/4 WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE HP STATED THE SUPPLY BAG FELL AND THE TUBING CAME OUT. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H11D29024) WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL. THE HP STATED THE SUPPLY BAG FELL AND THE TUBING CAME OUT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CLEARING THE ALARM THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND THAT THE HP COULD FINISH WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE CALL. THE HOME PATIENT (HP) STATED THE LINE DISCONNECTED BECAUSE THERE WAS A PROBLEM WITH THE CONNECTION ON THE LINE FROM THE CASSETTE. PER HP, THEY DID NOT RECEIVE ANY INJURY BUT WERE TAKING LEZOSLOXACIN AS RECOMMENDED BY THEIR REGISTERED NURSE (RN) AS A PROPHYLACTIC. THE HP STATED THAT THEY HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND PROVIDED THE LOT NUMBER FOR THE CASSETTE: H11D29024. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO MEDICAL INTERVENTION OR INJURY.

    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 H11D29024

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE