BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOCIE PRO

    MDR report key: 2241781 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11982
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 20, 2011
    Manufacturer
    BAXTER HEALTHCARE-SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR DAMAGED WAS CONFIRMED. DURING VISUAL INSPECTION A BROKEN BASE AND DOOR WAS FOUND. THE DEVICE BASE WAS REPLACED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. THE CAUSE WAS UNDETERMINED.

    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. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN ISSUE OF SHOCK WHICH OCCURRED ON HOME CHOICE (HC). THE HOME PATIENT (HP) STATED THE HP WAS ON VACATION AND THE HC WAS DAMAGED BY AIRLINES. THE HP STATED THAT THE UNIT CASE CRACKED BY THE CARD READER "PLUS." THE HP STATED THAT WHEN HE REACHED BEHIND THE UNIT TO SWITCH IT "ON", THE HC GAVE A SLIGHT SHOCK. THE HP STATED THAT HE WAS OKAY AND THERE WAS NO HARM. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) REFERRED THE HP TO CALL THE REGISTERED NURSE(RN) FOR FURTHER MEDICAL INSTRUCTIONS. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOCIE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE-SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1