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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LARGO HOMECHOICE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C4471R
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Heart Failure (2206)
Event Date 02/26/2014
Event Type  Death  
Event Description
This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice (hc).It is unknown if the patient was hospitalized prior to death.The cause of death was reported as cardiac failure.It was not reported if an autopsy was performed.Additional information was requested, but is not available.
 
Manufacturer Narrative
(b)(4).The device has been received by baxter, but the evaluation has not yet been completed.A follow-up report will be submitted upon completion of the evaluation or if any additional relevant information is received.
 
Manufacturer Narrative
(b)(4).The device was manufactured in 1995.The device was returned for evaluation.A review of the device logs revealed no system errors, anomalies, hardware device failures or increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported difficulty.The product analysis lab (pal) evaluated the device and no failure or malfunction were identified that could have caused or contributed to the home patient passing away.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.An internal and external inspection was performed and found no issues.The cycler remote toolbox (crt) was used to pressurize the device pneumatic system and all pressures were correct and stable.A short simulated therapy was performed and completed successfully.Review of the device service history and device history record 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
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - LARGO
7511 114th ave. north
largo FL 33773
Manufacturer (Section G)
BAXTER HEALTHCARE - LARGO
7511 114th ave. north
largo FL 33773
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3696592
MDR Text Key4291214
Report Number1416980-2014-09727
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 Consumer,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/27/2014
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 Number5C4471R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2014
Initial Date FDA Received03/24/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/16/2014
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 PD2 1.5% AND 2.5% SOLUTIONS
Patient Outcome(s) Death;
Patient Age67 YR
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