MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C4479C

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a leak was observed on the floor during use of a homechoice cassette.This was observed after completing peritoneal dialysis (pd) therapy.It was further reported that the leak was located closer toward the machine and "the clamps on the cassette did not make click sounds when secured".There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was discarded; however, a companion sample was received and evaluated.The companion sample was received unused and inside a closed pouch.Visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition.Homechoice machine testing was performed with no issues noted.The reported condition was not verified during the evaluation of the companion sample.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12514043
• MDR Text Key: 272743891
• Report Number: 1416980-2021-05852
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412088433
• UDI-Public: (01)00085412088433
• Combination Product (y/n): Y
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479C
• Device Lot Number: H21E29029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOMECHOICE DEVICE; UNSPECIFIED PD SOLUTION; HOMECHOICE DEVICE; UNSPECIFIED PD SOLUTION