HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

Description of Event or Problem

A HOME PT (HP) CONTACTED BAXTER'S TECHNICAL SVC CTR REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE DISPLAY OF THEIR HOMECHOICE MACHINE DURING INTIAL DRAIN. PER INITIAL REPORT, THE HOME PT DISCONNECTED/ RECONNECTED THEIR TRANSFER SET FROM THE PT LINE DURING THERAPY. THE BAXTER TECHNICAL SVC REP INSTRUCTED THE HOME PT TO RECYCLE POWER, DISCARD USED SUPPLIES, AND START THERAPY OVER USING NEW SUPPLIES. DURING A FOLLOW UP PHONE CALL REGARDING THE INITIAL 2240 ALARM, A BAXTER PRODUCT SURVEILLANCE SPECIALIST WAS NOTIFIED BY THE HOME PTS PERITONEAL DIALYSIS (PD) NURSE THAT THE HOME PT WAS TREATED FOR PERIONITIS (DIAGNOSIS DATE UNK) AND WAS DISCHARGED FROM THE HOSP IN 2006. THE HOME PT HAS MADE A FULL RECOVERY AND IS SCHEDULED TO VISIT THEIR PD IN FIVE DAYS. THE PD NURSE DOES NOT HAVE ACCESS TO LAB RESULTS, DIAGNOSIS COMMENTS, OR TREATMENT NOTES. THE HP'S NURSE WILL ATTEMPT TO OBTAIN THE HARD COPY OF THE HP'S DISCHARGE PAPERS / MEDICAL RECORD FROM THE ADMITTING HOSP AND FAX THE INFO TO BAXTER'S PRODUCT SURVEILLANCE BY 09/13/2006. NO FURTHER INFO IS AVAILABLE AT THIS TIME; AN ONGOING INVESTIGATION IS IN PROGRESS.

Additional Manufacturer Narrative

BAXTER'S PRODUCT SURVEILLANCE DEPT IS PURSUING ADDITIONAL INFO REGARDING THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.