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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - SINGAPORE HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C8310R
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Heart Failure (2206)
Event Date 12/18/2013
Event Type  Death  
Event Description
It was reported that a peritoneal dialysis (pd) patient (pt) who performed pd therapy with a homechoice (hc) device passed away due to cardiac failure.It was not reported if pd therapy was on-going until the time of death or if the pt was connected to the cycler at the time of death.Additional information was requested but is not available.
 
Manufacturer Narrative
Complaint no: cmplnt-(b)(4).Evaluation summary: the analysis lab received and evaluated the device.The device passed both the homechoice rite electrical test and the homechoice rite functional test and was determined to meet performance specification requirements per rite testing.No failure or malfunction was identified that could have caused or contributed to the home patient passing away.A review of the device logs revealed no system errors, anomalies, hardware device failures or iipv events that could have caused or contributed to the reported difficulty.Should additional relevant information become available, a follow-up will be submitted.
 
Manufacturer Narrative
(b)(4).Review of device history and service history revealed no failures/problems that was related to the patient's death and there was no indication that the parts replaced during servicing caused or contributed to the reported death.Upon conclusion of the investigation, the cause of the reported event could not be determined.Should additional relevant information become available, a follow-up report will be submitted.
 
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Brand Name
HOMECHOICE PRO
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore 2573
SN  2573
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore 2573
SN   2573
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3585788
MDR Text Key4188335
Report Number1416980-2014-02291
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102936
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/27/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number5C8310R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2014
Initial Date FDA Received01/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
DIANEAL PD4, 2.5% AMBUFLEX
Patient Outcome(s) Death;
Patient Age59 YR
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