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Adverse Event Report

BAXTER HEALTHCARE CORP. HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE   back to search results
Catalog Number 5C4469
Event Date 11/28/2003
Event Type  Malfunction  
Event Description

A home pt's spouse contacted baxter's technical service center regarding a system error 2240 message that appeared on the display of the home pt's homechoice machine during the initial drain cycle of automated peritoneal dialysis therapy. Reportedly, the home pt started the initial drain cycle prior to connecting transfer set to the pt line of the homechoice set. After noting this, the home pt connected to the setup. Baxter's technical service center assisted the home pt's spouse in ending their therapy early. The home pt completed therapy by setting up with new supplies. No pt injury or medical intervention was associated with this incident per the home pt's spouse.

 
Manufacturer Narrative

Baxter's quality assurance department has reviewed proper procedures with the home pt's spouse, in addition to referring them to their pt at-home guide for further detail.

 
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Brand NameHOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG
Type of DeviceHOMECHOICE CASSETTE
Baseline Brand NameHOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG
Baseline Generic NameHOMECHOICE CASSETTE
Baseline Catalogue Number5C4469
Baseline Device FamilyAPD DISPOSABLES, HOMECHOICE
Baseline Device 510(K) NumberK923065
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed03/04/1994
Manufacturer (Section F)
BAXTER HEALTHCARE CORP.
1900 highway, 201 north
mountain home AR 72653 2497
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
1900 highway, 201 north
mountain home AR 72653 2497
Manufacturer (Section G)
BAXTER HEALTHCARE CORP.
1900 hwy, 201 north
mountain home AR 72653 2497
Manufacturer Contact
christiana bielinski, manager
route 120 & wilson road
round lake , IL 60073
(847) 270 -6756
Device Event Key494277
MDR Report Key505410
Event Key478912
Report Number1423500-2003-01278
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Company Representative,Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 11/28/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number5C4469
Device LOT NumberNA01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/28/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/17/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2003
,01/01/2003
2,CAPD TRANSFER SET, 2003
,01/01/2003
3,DIANEAL PD2 SOLUTION (STRENGTH UNK), 2003.,01/01/2003

Database last updated on February 28, 2009

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