MAUDE Adverse Event Report: FRESENIUS HEMODIALYSIS CATHETER PRODUCTS

Lot Number 10061305

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  Injury  

Event Description

Crit chamber does not fit adequately into the dialyzer, causing blood to leak around it.Unable to use crit with dialyzer.Equipment removed from service.

• Brand Name: HEMODIALYSIS CATHETER PRODUCTS
• Type of Device: HEMODIALYSIS CATHETER PRODUCTS
• Manufacturer (Section D): FRESENIUS
• MDR Report Key: 6629503
• MDR Text Key: 77319265
• Report Number: MW5070257
• Device Sequence Number: 1
• Product Code: MSD
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Lot Number: 10061305
• Was Device Available for Evaluation?: No
• 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: 44 YR