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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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BAXTER HEALTHCARE CORPORATION HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C8310
Device Problem Unintended Electrical Shock (4018)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a homechoice presented an electric shock.This occurred during use of peritoneal dialysis therapy.The patient was not connected during the time of the event.It was further reported that the patient was getting electric shocks over time from using the machine.Continuous ambulatory peritoneal dialysis was discussed.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed.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 CORPORATION
deerfield IL
MDR Report Key9811553
MDR Text Key182768044
Report Number1416980-2020-01308
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K102936
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number5C8310
Was Device Available for Evaluation? No
Date Manufacturer Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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