MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number 5C4482

Device Problem Material Separation (1562)

Patient Problem Peritonitis (2252)

Event Date 06/21/2021

Event Type  Injury  

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 during use with a minicap transfer set, a peritoneal dialysis (pd) patient experienced a separation between the patient connector and tubing.Subsequently the patient developed peritonitis.The cause of the separation was not reported.It was not reported if the patient was hospitalized for the peritonitis event.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.Action with pd therapy was not reported.No additional information is available.

Manufacturer Narrative

A2: age at time of event: adult.B5: upon follow up it was reported a leakage was experienced following the separation.It was reported the patient was recovered from the peritonitis event.H10: the device and two photographs were received for evaluation in a wet condition with no pouch.Visual inspection with the naked eye and magnification observed no issues with the actual sample.Functional testing including leak testing, clear passage testing, and clamp function testing were performed with no issues noted.One photograph identified the patient adapter was slightly slipped back from the tubing/bushing indicating the separation between the two components occurred.The reported condition was verified.The cause of the condition could not be determined; however, a strong twist and pull on the patient adapter or the tubing could cause the two components to separate as the connection between the patient adapter and the tubing/bushing is a friction fitment and not a solvent bond.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12169717
• MDR Text Key: 261587463
• Report Number: 1416980-2021-04322
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): Y
• PMA/PMN Number: K152675
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 08/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other