BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1081778 · Received July 18, 2008

    Report

    Report Number
    1423500-2008-00667
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE DID NOT WISH RETURN THE HOMECHOICE MACHINE FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE HOME PATIENT (HP) WAS COMPLAINING OF SEVERE PAIN AT THE TOP OF HER ABDOMEN JUST BELOW HER LUNGS IN DWELL 1 OF 4 WITH THE HOMECHOICE (HC) MACHINE. ADDITIONALLY, THE HP WAS EXPERIENCING SHORTNESS OF BREATH. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH STOPPING DWELL AND STARTING A MANUAL DRAIN. THE HP DRAINED 2799 ML AND THE LAST VOLUME INFUSED WAS 2000 ML. THE HP JUST HAD HEART SURGERY. THE CALLER (HP'S DAUGHTER) STATED THAT SHE HAD PAGED THE PERITONEAL DIALYSIS NURSE. THE TSR LEFT THE HC MACHINE AT "STOPPED DWELL" UNTIL THE NURSE CALLED BACK. DURING FOLLOW UP, THE HP'S NURSE STATED THAT DIALYSIS IS BEING PERFORMED WITH THE PATIENT IN THE HOSPITAL ON THE DIALYSIS CLINIC'S MACHINE. THE PATIENT IS IN THE HOSPITAL RECOVERING FROM HEART SURGERY. THE NURSE REPORTED THAT THE PATIENT'S SYMPTOMS WERE A RESULT OF THE SURGERY. THE PATIENT HAD BEEN LYING FLAT ON HER BACK FOR SOME TIME AND HAD JUST STARTED TO STAND UP AND WALK AROUND WHEN SHE FELT THE PAIN. THE NURSE BELIEVES THAT CAUSE OF THE PAIN WAS THE PATIENT HEALING FROM HEART SURGERY AND NOT ASSOCIATED WITH OVERFILL. SHE STATED THE INCREASED DRAIN VOLUME WAS LIKELY DUE TO CATHETER POSITIONING IN THIS PATIENT. BECAUSE THE PATIENT WAS LYING COMPLETELY FLAT WHILE PERFORMING THERAPY, THE NURSE STATED THE TIP OF THE CATHETER MAY NOT HAVE BEEN POSITIONED PROPERLY TO DRAIN HER FULLY. INCOMPLETE DRAIN MAY HAVE CAUSED THE OVERFILL. THE NURSE STATED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE REPORTED SYMPTOMS OR THE OVERFILL AND THE HC MACHINE IS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR