BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 1760237 · Received July 16, 2010

    Report

    Report Number
    1423500-2010-01520
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ORIGINALLY THE DEVICE WAS NOT GOING TO BE RETURNED FOR EVALUATION BUT THE DEVICE WAS RETURNED AND EVALUATED. DEVICE EVALUATION: THE DEVICE WAS EVALUATED IN (B)(4) CENTRAL WORKSHOP. CONCLUSION CONCERNING THE EXACT CIRCUMSTANCES OF THE REPORTED EVENT CANNOT BE DRAWN. THE HOMECHOICE MACHINE DIDN'T CONTAIN THE INCRIMINATED THERAPY IN THE EVENT HISTORY LOG. INDEED THE LAST THERAPY THAT WAS RECORDED WAS THE THERAPY OF THE (B)(6) 2010 WHILE THE PROBLEM REPORTED WAS TO HAVE OCCURRED ON THE (B)(6) 2010. THE FOUR PERITONEAL DIALYSIS (PD) SESSIONS PRESENT ON THE MACHINE'S DATA LOG WERE UNEVENTFUL EXCEPT FOR SOME LOW DRAIN ALARMS AND CHECK PATIENT LINE ALARMS. ALL THERAPIES WERE TIDAL (95%) PD THERAPIES. IN ADDITION THE MACHINE WAS TESTED AND FOUND TO BE WORKING ACCORDING TO SPECIFICATION. UNFORTUNATELY A PROCARD WAS NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT UPDATE TO HOMECHOICEPRO. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING LETTER (B)(4).

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) ON (B)(4) 2010 FROM (B)(6) VIA A CLINICAL NURSE SPECIALIST, RENAL. IT WAS REPORTED THAT ON (B)(6) 2010 A HOMECHOICE PRO CARD WAS INVOLVED IN AN INCORRECT SETTING INCIDENT. AT THE TIME OF THE PROBLEM IT WAS REPORTED BY THE SISTER THAT SHE HAD AN ISSUE WITH A MALE PATIENT. THE PATIENT REQUIRED HIS DIALYSIS PRESCRIPTION TO BE ALTERED. THE SISTER WROTE A NEW PRESCRIPTION ONTO A PRO CARD FOR THE PATIENT USING THE RENALSOFT SOFTWARE. SHE ALSO PRINTED OUT A COPY OF THE NEW PRESCRIPTION FOR HER OWN RECORDS THEN GAVE THE PATIENT HIS PRO CARD CONTAINING HIS NEW PRESCRIPTION FOR HIM TO INSERT INTO HIS HOMECHOICE MACHINE WHEN HE GOT HOME, PRIOR TO STARTING HIS DIALYSIS THAT EVENING. THREE DAYS LATER, THE PATIENT'S WIFE CONTACTED THE SISTER TO SAY THAT HER HUSBAND WAS NOT WELL SINCE CHANGING HIS DIALYSIS PRESCRIPTION THREE DAYS EARLIER, SHE STATED THAT HE HAD BECOME FLUID OVERLOADED. THE SISTER ASKED THE PATIENT'S WIFE TO READ OUT THE PRESCRIPTION ON THE MACHINE TO HER OVER THE TELEPHONE. WHEN THE PATIENT'S WIFE DID THIS IT WAS BROUGHT TO THE SISTER'S ATTENTION THAT ALTHOUGH SHE HAD PRESCRIBED A TIDAL THERAPY OF 95%, THE HOMECHOICE MACHINE HAD REVERTED BACK TO THE FACTORY SETTING OF 5%. THE SISTER TALKED THE PATIENT'S WIFE THROUGH HOW TO CHANGE THIS SETTING TO TIDAL 95% DURING THEIR TELEPHONE CONVERSATION THE SISTER THEN CHECKED THE PRINT OUT OF THE NEW PRESCRIPTION SHE HAD IN HER RECORDS TO CHECK THAT SHE HAD NOT MADE AN ERROR WHEN WRITING THE NEW PRESCRIPTION ONTO THE PRO CARD. THE PRESCRIPTION SHEET SHOWED THE TIDAL SETTING BEING THAT OF 95%. THE PATIENT MADE A FULL RECOVERY ONCE THE CORRECT PRESCRIPTION WAS PROGRAMMED INTO THE HOMECHOICE MACHINE MANUALLY. SAMPLE IS NOT AVAILABLE FOR EVALUATION BUT THE PRINT OUTS ARE GOING TO BE MADE AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED TO ATTACHMENTS INTERNATIONAL, INC. THAT AN IMZ 3.3 IME SCREW HAD FRACTURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention