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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 Problems Degraded (1153); Volume Accuracy Problem (1675)
Patient Problem No Patient Involvement (2645)
Event Date 10/02/2014
Event Type  malfunction  
Event Description
During evaluation of a returned homechoice device, a baxter technician determined the machine failed rite (returned instrument test/evaluation) testing for fluid volume accuracy.Device failed during evaluation, no patient involved.
 
Manufacturer Narrative
(b)(4).The homechoice was returned and the evaluation is ongoing.Should additional relevant information become available, a follow-up report will be submitted.
 
Manufacturer Narrative
(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported issue.An internal and external inspection was performed with no abnormalities noted.The device passed the homechoice rite (return instrument test/evaluation) electrical test but failed the homechoice rite functional test.The direct cause of the reported problem was determined to be due to deteriorated piston foam.A service history review was conducted and there were no deviations noted that could have caused or contributed to the reported event during the service of this device.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 Key4204008
MDR Text Key5037162
Report Number1416980-2014-37613
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 10/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5C8310R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/03/2014
Initial Date FDA Received10/27/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/28/2014
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
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