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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); Myocardial Infarction (1969); Heart Failure (2206)
Event Date 03/23/2014
Event Type  Death  
Event Description
It was reported that a peritoneal dialysis (pd) patient (pt) who performed therapy with a homechoice device (hc) passed away.The cause of this death was reported to be cardiac failure.Four days prior to death, the pt was hospitalized for a myocardial infarction.It was unknown if the pt was on the home choice device at the time of death.An autopsy was not performed.Additional information was requested but was not available.
 
Manufacturer Narrative
(b)(4).Should additional relevant information become available, a follow-up will be submitted.
 
Manufacturer Narrative
(b)(4).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 event.The product analysis lab (pal) evaluated the device and no failures or malfunctions were identified that could have caused or contributed to the patient passing away.The device was determined to meet electrical performance specification requirements per return instrument test/ evaluation (rite) testing.The device failed the homechoice rite functional testing, however, it was determined that the failure was unrelated to the reported event.An internal and external inspection was performed and found no issues.An evaluation of the device pneumatic system revealed no leaks and all pressures were correct & stable.The device also passed seal, purge & wet disposable integrity tests.A short simulated therapy was performed successfully.Review of the device service history revealed no issues that could have caused or contributed to the home patient passing away.Upon conclusion of the investigation, no abnormalities or failures were identified that could have caused or contributed to the 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 Key3812056
MDR Text Key4369414
Report Number1416980-2014-15556
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 04/24/2014
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 Manufacturer05/06/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2014
Initial Date FDA Received05/15/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/14/2014
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 PD-4 1.5% AND 2.5% AMBUFLEX
Patient Outcome(s) Death; Hospitalization;
Patient Age67 YR
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