BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 536956 · Received March 10, 2004

    Report

    Report Number
    1423500-2004-00215
    Event Type
    Other
    Date Received
    March 10, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 5, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOMEPATIENT (HP) REPORTED THE SUSPICION THAT THE HOMECHOICE MACHINE MAY BE "PUSHING AIR INTO THE ABDOMEN" DURING THE HP'S AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. REPORTEDLY, IN 2004 AFTER COMPLETION OF APD THERAPY THE HP EXPERIENCED PAIN IN THE RIGHT SIDE. THE PAIN FELT SIMILAR TO AN AIR INFUSION, BUT SUBSIDED THROUGHOUT THE DAY. THE NEXT DAY AFTER COMPLETION OF APD THERAPY THE HP AGAIN EXPERIENCED ABDOMINAL PAIN, WHICH SEEMED MORE SEVERE THAN THE PREVIOUS DAY. PER THE HP PT SUSPECTED PT MAY HAVE PERITONITIS AND SUBSEQUENTLY PERFORMED A MANUAL EXCHANGE AND ADDED HEPARIN INTO THE FILL BAG, HOWEVER, THE DRAIN FLUID WAS CLEAR AND NOT CLOUDY. TWO DAYS LATER, AFTER COMPLETION OF THE APD THERAPY, THE HP EXPERIENCED EVEN MORE SEVERE ABDOMINAL PAIN AND HAD DIFFICULTY STANDING UP STRAIGHT. PER THE HP, THIS TIME THE PAIN WAS ALSO IN THE SHOULDER. PER THE HP'S NURSE, THE HP CONTACTED THE DIALYSIS CLINIC AND BROUGHT IN A SAMPLE OF THE EFFLUENT. AN EFFLUENT CULTURE AND CELL COUNT WAS PERFORMED TO RULE OUT PERITONITIS. THE RESULTS SHOWED NO EVIDENCE OF AN INFECTION. AN X-RAY WAS PERFORMED ON THE HP'S ABDOMINAL AREA WHICH SHOWED THAT THE CATHETER POSITIONING WAS GOOD, AND THE CATHETER WAS INTACT. THE NEPHROLOGIST ADVISED THE HP TO TAKE 2 EXTRA STRENGTH TYLENOL AT NIGHT FOR THE SHOULDER PAIN. DURING THE FIRST FILL OF THE APD THERAPY TWO DAYS LATER PT BEGAN FEELING PAIN. AT THIS POINT, THE HP DISCONTINUED APD THERAPY, AND COMPLETED THERAPY MANUALLY. REPORTEDLY, THE HP STARTS THERAPY WITH A FULL PERITONEUM, AND NO PT LINE EXTENSIONS WERE BEING USED DURING ANY OF THE EVENTS. PER THE HP DURING APD THERAPY TWO DAYS LATER PT DID NOTE AIR BUBBLES IN THE PT LINE BUT NO LEAKS OR DISCONNECTIONS WERE NOTED WITH THE SETUP. THE HP CONTACTED BAXTER'S TSC TO REQUEST A REPLACEMENT HOMECHOICE MACHINE THE DAY AFTER. PER THE HP'S NURSE, THE ISSUE HAS RESOLVED SINCE THE PT RECEIVED THE REPLACEMENT CYCLER. AN EVALUATION IS ANTICIPATED FOR THE SWAPPED HOMECHOICE MACHINE RECEIVED BY BAXTER'S PRODUCT ANALYSIS LAB IN A MONTH AS WELL AS THE HOMECHOICE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA H03K13107

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other 1) HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2004,| 4) 12 FT. EXTENSION SET, 2004.| 3) DIANEAL LOW CALCIUM SOLUTION(STRENGTH UNK),2004| 2) CAPD TRANSFER SET, 2004,