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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 5C8310
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Heart Failure (2206); Multiple Organ Failure (3261)
Event Date 01/08/2014
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 disease.On an unknown date in the month prior to death, the pt was hospitalized for another indication.On an unreported date in the same month as being admitted, the pt was discharged from the hospital and went home on hospice care.Subsequently, the pt died.The cause of death was reported to be due to cardiac disease.The cause of death was further described as possibly due to multi-system organ failure, however, this was not confirmed.Pd therapy was ongoing until the time of death.The pt was not connected to the hc at the time of death.It was unknown if an autopsy was performed.Additional information was requested but is not available.
 
Manufacturer Narrative
(b)(4).Should additional relevant information become available, a follow-up medwatch will be submitted.
 
Manufacturer Narrative
(b)(4).A review of the device history revealed no issues that could have caused or contributed to the patient passing away.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4).The serial number ((b)(4)) and catalog number (5c8310r) that were previously reported were incorrect and the actual sn and catalog number associated with this patient were sn (b)(4) and catalog number 5c8310.As the device was not linked to the reported death until after the device had been serviced, a complete device analysis could not be completed to investigate the reported death.However, a review of the device logs revealed no system errors, anomalies, hardware device failures or intraperitoneal volume iipv events that could have caused or contributed to the reported difficulty.The device passed both the homechoice rite (return instrument test/evaluation) electrical test and the homechoice rite functional test and was determined to meet performance specification requirements per rite testing.Review of the service history revealed no issues that could have caused or contributed to the home patient passing away.Should additional relevant information become available, a supplemental 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 FL 33773 257
SN  33773 2573
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore FL 33773 257
SN   33773 2573
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3606473
MDR Text Key4067210
Report Number1416980-2014-03401
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,Followup
Report Date 01/10/2014
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 Number5C8310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/08/2014
Initial Date FDA Received02/04/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/25/2014
06/02/2014
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% ULTRABAG; DIANEAL PD4 2.5% AMBUFLEX
Patient Outcome(s) Death;
Patient Age62 YR
Patient Weight75
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