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

Catalog Number 5C4482

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 03/15/2021

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 transfer set separated (not further specified).It was further reported that there was leakage from the twist clamp of the transfer set.The nurse detected this issue at the hospital room during continuous ambulatory peritoneal dialysis (capd) treatment.It was further stated that the transfer set was kept clean without using additional disinfectant.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: d9, h3, h6.H10: one actual sample was received for evaluation.A visual inspection with the naked eye and magnification was performed which noted the silicone tubing was twisted inside the main body of the twist clamp.The occlude feet were intact and no other issues were observed.Clear passage testing was performed which revealed no flow through the set.Leak testing was performed with no issues noted.The reported condition of leak was not verified, however, the sample failed to meet specification due to no flow through the set.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to (b)(6) 2021.

• 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: 11657305
• MDR Text Key: 245236095
• Report Number: 1416980-2021-02089
• 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,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.