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Adverse Event Report

BAXTER HEALTHCARE CORPORATION HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE   back to search results
Catalog Number 5C4469
Event Date 02/25/2004
Event Type  Malfunction  
Event Description

A system error 2240 message appeared on the display of the home pt's homechoice machine during drain 1 of automated peritoneal dialysis therapy. Reportedly, the home pt disconnected their transfer set from the pt line of the homechoice set. The home pt noted that the homechoice machine was alarming. Hp reconnected self to the setup and attempted to proceed with therapy. Baxter's technical service center assisted the home pt in ending the therapy early. Therapy was completed manually. No pt injury or medical intervention was associated with this incident per the home pt.

 
Manufacturer Narrative

Baxter's quality assurance dept has reviewed proper procedures with the home pt in addition to referring them to the home pt's nurse for local procedures.

 
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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 CORPORATION
1900 hwy, 201 north
mountain home AR 72653 2497
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
1900 hwy, 201 north
mountain home AR 72653 2497
Manufacturer (Section G)
BAXTER HEALTHCARE CORP
1900 highway, 201 north
mountain home AR 72653 2497
Manufacturer Contact
christiana bielinski, mgr
rt 120 & wilson rd
round lake , IL 60073
(847) 270 -6756
Device Event Key521915
MDR Report Key532641
Event Key505688
Report Number1423500-2004-00206
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/25/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2004
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 Received02/25/2004
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: 03/11/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2004
,01/01/2004
2,CAPD TRANSFER SET, 2004
,01/01/2004
3,DIANEAL PD2 SOLUTION (STRENGTH UNKNOWN), 2004.,01/01/2004

Database last updated on January 30, 2009

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