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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 R5C8320
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received and the evaluation is complete. During the event history log review, an increased intra-peritoneal volume (iipv) event was identified. Upon conclusion of the investigation, the cause of this issue was determined to be use error, tidal total ultrafiltration removal set too low. The homechoice apd systems trainer¿s guide gives instructions on how to set the tidal therapy settings. A review of the label for the product family will be conducted. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
During evaluation of a returned homechoice device, one increased intra-peritoneal volume (iipv) event was identified. This event occurred in the therapy initiated on (b)(6) 2015 at 23:42:42. During night drain cycle seven, the patient's ultrafiltration reading was 1871ml, indicating the home patient drained 1431ml more than their maximum programmed fill volume of 2200ml. No additional information is available.
 
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Brand NameHOMECHOICE PRO
Type of DeviceSYSTEM, 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
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4946257
MDR Text Key13711709
Report Number1416980-2015-30376
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Type of Report Initial
Report Date 07/06/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberR5C8320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2015
Date Manufacturer Received07/06/2015
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

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