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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LARGO 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 09/24/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was returned to baxter healthcare for evaluation.A review of service history revealed previous device servicing did not cause or contribute to the reported difficulty.A review of the device logs did not verify the reported issue of a returned instrument testing evaluation (rite) functional test failure during the volumetric accuracy test.An internal and external inspection was performed on the device and the device passed.The device passed rite electrical testing.A manual volumetric accuracy test was performed and the device failed.The door piston foam was replaced with a test article and the manual volumetric accuracy test passed specifications.The original door piston foam was found to be too deteriorated to place back into the device.A manual temperature test was completed and passed specifications.A check of the door assembly found the door piston cracked at the side of the left disposable.The cause for the rite functional test failure for volumetric accuracy was determined to be caused by deteriorated door piston foam and cracked door piston.The piston and foam were replaced to resolve the problem.This issue is being investigated through a capa.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
During evaluation of a returned homechoice (hc) device, a baxter technician determined the hc machine failed fluid volume accuracy testing.Device failed during evaluation, no patient involved.
 
Manufacturer Narrative
(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a follow-up report will be submitted.
 
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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 Key4183859
MDR Text Key12495257
Report Number1416980-2014-36509
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 09/24/2014
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 Manufacturer09/24/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/29/2014
Initial Date FDA Received10/19/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/24/2014
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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