BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2832345 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05153
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS OPERATIONAL AND WAS NOT RETURNED FOR EVALUATION. THE PRODUCT ANALYSIS LAB (PAL) CONFIRMED THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV) BASED ON REPORTED INFORMATION. THE ASSIGNABLE CAUSE WAS FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED. REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING THE MACHINE NOT DRAINING THEM, WHICH OCCURRED ON THE HOMECHOICE PRO (HCP) DURING USE, DURING DWELL 1. THE PATIENT REPORTED BEING BLOATED WITH SYMPTOMS OF ABDOMINAL PAIN/DISCOMFORT. THE INITIAL DRAIN ALARM WAS SET TO 0ML. THE HOME PATIENT (HP) DOES A 2L MIDDAY EXCHANGE. THE HP DRAINED 14ML. IN DRAIN 1, THE PATIENT DRAINED JUST OVER 2500ML, AND IT JUMPED TO FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) STOPPED THE DRAIN AND DID A MANUAL DRAIN AND GOT OUT ANOTHER 3087ML. THE PATIENT'S LAST FILL VOLUME IS 2600ML. BASED ON THE COMBINED DRAIN VOLUME, THIS COMPLAINT MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA (ANY THERAPY WHERE THE PATIENT VOLUME EXCEEDS 160% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME). THE ALARM FOR INITIAL DRAIN LOOKED TO BE INCORRECTLY SET. THERAPY WAS ENDED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE REGISTERED NURSE (RN) ON (B)(6) 2012 REGARDING THE EVENT. THE NURSE WAS AWARE OF THE OCCURRENCE. SHE STATED THAT THE PATIENT HAS BEEN HOSPITALIZED. SHE STATED THAT SHE WAS NOT SURE WHY THE PATIENT WAS HOSPITALIZED OR IF IT WAS RELATED TO THIS EVENT. SHE STATED, SHE WAS NOT SURE IF IT WAS RELATED TO BAXTER PRODUCTS. THE NURSE STATED THAT THE PATIENT IS CURRENTLY STILL AT THE HOSPITAL AND STATED THAT SHE HASN'T HEARD FROM HIM. PS INFORMED THE NURSE THAT THE OVERFILL MAY HAVE BEEN CAUSED FROM THE PATIENT'S INITIAL DRAIN ALARM SETTING. THE NURSE STATED SHE WOULD LOOK AT THIS SETTING. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT SURVEILLANCE MADE CONTACT WITH THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2012 REGARDING THE REPORTED INCIDENT. THE NURSE REPORTED THAT SHE HAS RECENTLY SPOKEN WITH THE PATIENT'S DAUGHTER AND THE PATIENT'S PHYSICIAN REGARDING THE HOSPITALIZATION. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 FOR A GASTROINTESTINAL BLEED AND WAS DISCHARGED ON (B)(6) 2012. PERITONEAL DIALYSIS THERAPY WAS ONGOING DURING THE PATIENT'S HOSPITALIZATION. THE NURSE REPORTED, THE PATIENT HAS HAD A HISTORY OF PREVIOUS GASTROINTESTINAL BLEEDS. THE PERITONEAL DIALYSIS NURSE REPORTED, THE REASON FOR THE HOSPITALIZATION WAS UNRELATED TO PERITONEAL DIALYSIS, A BAXTER DEVICE, DISPOSABLES, OR SOLUTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE