MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C8320

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a home patient (hp) received an over delivery of solution during therapy with a homechoice pro automated pd system.This was described as the pd registered nurse ¿gave five liters of infusion to the hp and there were no alarms that occurred¿.The hp was connected at the time of the event.This occurred during an unspecified process step of peritoneal dialysis (pd) therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information in d10, h3, h6.H10: the device was received for evaluation.A simulated therapy was successfully performed on the device.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The reported condition was not verified.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 HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10620101
• MDR Text Key: 209589968
• Report Number: 1416980-2020-06145
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOMECHOICE CASSETTE; UNSPECIFIED SOLUTION; HOMECHOICE CASSETTE; UNSPECIFIED SOLUTION