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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 Problem Overfill (2404)
Patient Problem Abdominal Pain (1685)
Event Date 03/29/2013
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has been received by baxter, but the evaluation has not yet been completed. A follow-up mdr will be submitted upon completion of the evaluation or if any additional relevant information is received.
 
Manufacturer Narrative
(b)(4). The device was returned and evaluated by the product analysis lab (pal). The increased intra-peritoneal volume (iipv) was confirmed by review of the logs. The cause was found to be false empty detect and use error with initial drain alarm setting inappropriately programmed. The device passed all functional testing during evaluation and was sent for service. Homechoice / homechoice pro apd systems patient at-home guide states in the warnings: setting the i-drain alarm volume too low or off can result in an incomplete initial drain followed by a full fill. This can result in an increased intraperitoneal volume (iipv) situation. H6 additional method code ? 3372.
 
Event Description
The customer contacted baxter's technical service center to report an overfill situation on a homechoice (hc) device. The home patient (hp) told the peritoneal dialysis registered nurse (pdrn) that he had felt overfilled and had abdominal pain. The hp said the hc filled with the prescribed fill volume (fv) of 3000ml in fill 2 of 5. Then the hp stated that the hc only drained 300ml and moved to the next fill. The hp reported having pain in fill 3 of 5 and bypassed to drain before ending therapy early. The hp reported having no alarms. The pdrn does not have access to the hc and the hp is at the clinic. The hp was not connected and did not have symptoms at the time of the call. The baxter technical service representative (tsr) initiated a swap of the device. The tsr discussed the use of continuous ambulatory peritoneal dialysis (capd) until the new machine arrives. There was patient involvement, but no patient injury or medical intervention indicated at the time of the initial report. Evidence of a high drain alarm was found in the event history log review during evaluation of this device, which coincides with the date of the reported overfill. This indicates the patient drained greater than 200% of the maximum prescribed cycle fill volume in standard mode, and meets criteria for increased intra-peritoneal volume (iipv).
 
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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
virginia mckinney
25212 w. illinois route 120
round lake, IL 60073
8472702835
MDR Report Key3070317
MDR Text Key10728038
Report Number1416980-2013-09954
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,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5C8310R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2013
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 Treatment Data
Date Received: 04/22/2013 Patient Sequence Number: 1
Treatment
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
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