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

Catalog Number L5C4531

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a pin hole in the patient line of an integrated apd set w/cassette which resulted in a leak; further described as "near the clamp".This occurred during fill one of four of peritoneal dialysis (pd) therapy.Renal therapy services assisted the patient in ending the therapy session.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a hole (damage) in the patient line tubing.Functional testing including clear passage testing and clamp function testing were performed with no issues noted.Leak testing was performed, and it was noted that there was a leak at the location of the hole in the tubing.The reported condition was verified.The cause of the condition could not be determined.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
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16777364
• MDR Text Key: 313668049
• Report Number: 1416980-2023-01887
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HOMECHOICE CLARIA DEVICE; UNSPECIFIED PD SOLUTION