MAUDE Adverse Event Report: BAXTER HEALTCARE-LARGO HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C8320

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an overinfusion while connected to a homechoice device.The tidal therapy has a prescribed fill volume of 2200ml with 75% tidal.The patient reported that the machine has been overfilling, delivering the full 2200ml per fill.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received and an evaluation is complete.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Visual inspection and functional tests were performed.Electrical safety testing was performed.A short simulated therapy was successfully performed.The reported condition was not verified.The cause was undetermined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTCARE-LARGO; largo FL
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6125689
• MDR Text Key: 60858299
• Report Number: 1416980-2016-17621
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1