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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 01/08/2014
Event Type  Death  
Event Description
This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice.It was not reported 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).A request for the return of the device has been made.Should the device be received by baxter for evaluation, a follow-up report will be filed upon completion of an evaluation or if any additional information becomes available.
 
Manufacturer Narrative
(b)(4).Evaluation summary: the device was received for evaluation.Visual inspection, electrical testing, and functional testing were performed and passed with relationship to the reported condition.A simulated patient therapy test, accuracy test, and temperature test were performed and passed.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 event.A device history review was performed and found that the device had previously failed pneumatic testing.The device was retested and passed subsequent testing.A service history record review was performed and revealed no issues that could have caused or contributed to the reported condition.No device malfunction or iipv was confirmed related to the reported condition.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 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 Key3604332
MDR Text Key4157462
Report Number1416980-2014-03264
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,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/09/2014
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 Number5C8310R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/05/2014
Initial Date FDA Received02/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/28/2014
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 LOW CALCIUM 1.5% SOLUTION; DIANEAL LOW CALCIUM 2.5% SOLUTION
Patient Outcome(s) Death;
Patient Age59 YR
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