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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 10/03/2014
Event Type  malfunction  
Event Description
During evaluation of a returned homechoice device, a baxter technician determined the homechoice machine failed fluid volume accuracy testing.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).The device received a returned instrument testing evaluation (rite), which included functional and electrical testing of the device, and the device failed the manual volumetric accuracy test.The service history review revealed a previous service event of the door piston foam being replaced.Upon completion of the investigation, the cause of the reported problem was identified to be deteriorated piston foam.The piston foam was replaced.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 - 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 Key4208212
MDR Text Key5042700
Report Number1416980-2014-37816
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
Report Date 10/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2014
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 Manufacturer09/25/2014
Date Manufacturer Received10/03/2014
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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