BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2002028 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02475
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 2 ASSOCIATED WITH THIS DEVICE. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) OCCURRED DURING DWELL WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. THE HOME PATIENT (HP) SAID HE REMOVED CLAMP FROM UNUSED SUPPLY LINE AND PUT IT ON DRAIN LINE. THE HP STATED HE HAD TIED LINE IN A KNOT AFTER REMOVING CLAMP. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2011 DURING DRAIN CYCLE 2. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 2600 ML AND THE DRAIN VOLUME WAS 4784 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE HOME PATIENT (HP) TO OBTAIN ADDITIONAL INFORMATION AS REQUESTED BY THE QUALITY ENGINEERS REGARDING THE IIPVS FOUND DURING THE DEVICE EVALUATION, IT WAS REVEALED THAT HER ULTRAFILTRATE (UF) RANGES FROM -20 TO -300ML. THE HP STATED THAT SHE MUST HAVE BEEN ON THE DRAIN CYCLE FOR A LONG TIME ON THE DAY THE IIPV OCCURRED. PER THE HP, SHE USES ONE 2.5% AND ONE 4.25% SOLUTION CONCENTRATIONS. PER THE HP, SHE DID NOT EXPERIENCE ANY SYMPTOMS OR PAIN ON DRAIN. THE HP STATED THAT SHE PERFORMS OFF-CYCLER EXCHANGES IF HER UF VALUES FALL BELLOW -100ML. INCIDENTALLY, THE HP'S PERITONEAL DIALYSIS (PD) NURSE WAS VISITING THE HP AT THE TIME OF THIS CALL, SO THIS WRITER SPOKE WITH THE PD NURSE AS WELL. PER NURSE, THE VARIABILITY SEEN IN THIS HP'S DRAIN VOLUMES IS NOT NORMAL; HOWEVER, THE NURSE ADDED THAT THE HP DOES NOT RECORD ALL THE DRAIN VOLUMES. THE NURSE STATED THAT THE HP HAS PRE-EXISTING CONDITIONS OF HYPERTENSION, EDEMA, DIABETES. PER NURSE, THE HP IS NOW ON A TOTAL FILL VOLUME OF 8000ML. THE NURSE DID NOT THINK HP HAD PROBLEMS WITH HER CATHETER, BUT SHE SUGGESTED THAT THE HP HAS TO START REPOSITIONING HERSELF TO HELP DRAIN BETTER. PRODUCT SURVEILLANCE ALSO NOTIFIED THE PD NURSE OF THE IIPVS FOUND DURING THE REVIEW OF THE LOGS. THE NURSE WONDERED IF THESE IIPVS WERE RELATED TO HP POSSIBLY BYPASSING THE DRAINS ALSO AND NOT REPOSITIONING TO ALLOW DRAIN TO FLOW. NO FURTHER INFORMATION WAS PROVIDED. A MEDICAL ASSESSMENT WAS ALSO PERFORMED RELATED TO THE SYMPTOMS REPORTED, AND IT WAS DETERMINED THAT SINCE THE PATIENT ALSO HAS A PRIOR HISTORY OF HYPERTENSION AND EDEMA, IT IS UNLIKELY THAT THE HC MACHINE CAUSED OR CONTRIBUTED TO THESE ISSUES. THERE IS NO SERIOUS INJURY OR INTERVENTION TO PREVENT SUCH A SERIOUS INJURY RELATED TO A BAXTER DEVICE REPORTED IN THIS COMPLAINT. THIS IS NOT A MDR REPORTABLE SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR