MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP-EXTRA SHORT; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number 5C4483

Device Problems Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

Patient arrived to clinic for adequacy collection and presented with transfer set still attached to (amia cycler) patient line.Patient reports attempting to disconnect from patient line, the navy tip of the transfer set detached.Patient reports that transfer set was closed and patient line was clamped as he was attempting to disconnect.

• Brand Name: MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP-EXTRA SHORT
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16111408
• MDR Text Key: 306798962
• Report Number: 16111408
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2022

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 Model Number: 5C4483
• Device Catalogue Number: 5C4483
• Device Lot Number: H21K15043
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8760 DA
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic
• Patient Race: White