• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE - LARGO HOMECHOICE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C4471R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Unspecified Infection (1930); Renal Disease, End Stage (2039); Heart Failure (2206)
Event Date 04/24/2014
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 death was reported to be cardiac failure, diabetes, renal disease, and an infection related to an amputation.It was unknown if therapy was ongoing until the time of death.It was not reported if an autopsy was 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 to baxter healthcare for further investigation.A review of the event history log revealed no failure, malfunction or increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported problem.Internal and external visual inspections were performed and revealed no problems.The device passed both the electrical and functional testing.Analysis of the device pneumatic system revealed no leaks and all pressures were correct and stable.The device passed seal, purge & wet disposable integrity tests.A short simulated therapy was performed on the device successfully.The results of the sample analysis revealed no failure or malfunction were identified that could have caused or contributed to the patient passing away.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key3830318
MDR Text Key4497148
Report Number1416980-2014-16752
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 04/28/2014
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 Manufacturer06/09/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/14/2014
Initial Date FDA Received05/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/08/2014
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 1.5% ULTRABAG, DIANEAL 1.5% AMBUFLEX
Patient Outcome(s) Death;
Patient Age59 YR
-
-