MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problems Contamination (1120); Disconnection (1171); Improper or Incorrect Procedure or Method (2017); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2021

Event Type  malfunction  

Event Description

Pd transfer set malfunction resulting in missed treatment and transfer set change for prevention.Tip of transfer set became disconnected and remained inside minicap, exposing catheter.Will continue to reinforce importance of clean technique with connection/disconnection and crucial importance of notifying clinic of possible contamination.

• Brand Name: MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11321111
• MDR Text Key: 231610167
• Report Number: 11321111
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2021

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2021
• Event Location: Home
• Date Report to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1