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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  
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.
 
Manufacturer Narrative
(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported problem.A review of the event history log did not identify issues related to the reported problem.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.An internal and external visual inspection revealed no problems.A check of the pneumatic system found all pressures to be correct and stable.The device passed the returned instrument testing evaluation (rite) electrical testing but failed the rite functional testing due to multiple fills and drains being outside of volumetric specifications.A test article piston foam was installed and the device was able to pass the volumetric accuracy testing.The direct cause of this problem was deteriorated piston foam.The deteriorated piston foam was scrapped to solve the problem.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 Key4182921
MDR Text Key5093175
Report Number1416980-2014-36413
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 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 Manufacturer10/23/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/07/2014
Initial Date FDA Received10/17/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/02/2014
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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