FDA Adverse Event Injury Summary report: N

HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

MDR report key: 556242 · Received November 23, 2004

Report

Report Number
1423500-2004-01206
Event Type
Injury
Date Received
November 23, 2004
Date of Event
October 28, 2004
Report Date
October 28, 2004
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
FKX
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

THE HOME PT (HP) REPORTED FEELING FULL AND EXPERIENCED SHORTNESS OF BREATH, AS IF PT WERE OVERFILLED, WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HP INITIATED APD THERAPY AND ENCOUNTERED A "LOW DRAIN VOLUME" ALARM DURING THE INITIAL DRAIN AFTER DRAINING 2MLS, WHICH INDICATES THAT A LOW FLOW/NO FLOW CONDITION HAS OCCURRED AND THE INITIAL DRAIN ALARM SETPOINT OF 1400MLS HAS NOT YET BEEN MET. THE HP BYPASSED THE ALARM AND CONTINUED APD THERAPY UNTIL DWELL 2 OF 5 WHEN PT FELT FULL. THE HP PLACED THE CYCLER INTO A MANUAL DRAIN AND REMOVED 1034MLS; HOWEVER, PT CONTINUED TO FEEL FULL AND BYPASSED INTO DRAIN 2 OF 5. APD THERAPY CONTINUED INTO FILL 3 OF 5, AT WHICH TIME THE CYCLER ELICITED A "CHECK LINES AND BAGS" ALARM. A "CHECK LINES AND BAGS" ALARM INDICATES THAT ONE OR MORE OF THE SET LINES ARE CLOSED OR SOLUTION BAGS ARE EMPTY. THE HP RELATED THAT BOTH ON THEIR SOLUTION BAGS WERE EMPTY. THE HP THEN PERFORMED A MANUAL DRAIN AND REMOVED 6675MLS OF SOLUTION, AFTER WHICH PT DISCONTINUED APD THERAPY FOR THE NIGHT. THE HP SUBSEQUENTLY REQUESTED A REPLACEMENT CYCLER. PER THE HP, THERE WAS NO RESULTING INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORPORATION NA NA

Patients

Seq Age Sex Outcome Treatment
1 64 YR Other 4.25%, 2004, MINICAP DISCONNECT CAP, 2004,| HOMECHOICE APD SET WITH CASSETTE 4-PRONG, 2004.| SOLUTION 1.5%, 2004, DIANEAL LOW CALCIUM SOLUTION| 15L APD DRAINAGE BAG, 2004, DIANEAL LOW CALCIUM