MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP TRANSFER SET 6 INCH; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number SC4482

Device Problems Misconnection (1399); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  Injury  

Event Description

Upon disconnection from pd treatment, pt noticed the tip of the transfer set was almost completely pulled away from the handle portion of transfer set.When applying the new minicap, pt pushed really heard on the transfer set to return the dark blue portion to the correct position then called the clinic right away.

• Brand Name: MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP TRANSFER SET 6 INCH
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION ; deerfield IL 60015
• MDR Report Key: 11760082
• MDR Text Key: 248797825
• Report Number: MW5101104
• Device Sequence Number: 1
• Product Code: KDJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC4482
• Device Lot Number: H19L09048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 69