• 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 PRO; 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 PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C8310R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Heart Failure (2206)
Event Date 12/16/2013
Event Type  Death  
Manufacturer Narrative
(b)(4).The device was received for evaluation.The device passed electrical and functional testing.An internal and external inspection was performed and found no issues.A review of the device event log revealed no system errors, anomalies, hardware device failures or increased intraperitoneal volume (iipv) events.A review of the device history and service history records showed no abnormalities that could cause or contribute to the reported event.The cause of the reported event could not be determined.The device was determined to meet all functional and electrical specifications.If additional relevant information is received, a supplemental medwatch will be filed.
 
Event Description
This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice.The patient had been hospitalized three days prior to their death for worsening heart failure.The cause of death was reported to be heart failure.Therapy was ongoing at the time of death.The patient was performing therapy when they died.It was not reported if an autopsy was performed.Additional information was requested, but is not available.
 
Manufacturer Narrative
(b)(4).If additional relevant information is received, a supplemental medwatch will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HOMECHOICE PRO
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 Key3568628
MDR Text Key11527679
Report Number1416980-2014-01276
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 12/17/2013
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 Manufacturer01/08/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/14/2014
Initial Date FDA Received01/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2002
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
2.5% DIANEAL PD4 AMBUFLEX; 1.5% DIANEAL PD4 AMBUFLEX,
Patient Outcome(s) Death;
Patient Age63 YR
-
-