MAUDE Adverse Event Report: FRESENIUS USA, INC. CRIT-LINE®; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number CL10041021

Device Problem Structural Problem (2506)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Critline clic blood chambers from fresenius have a weakness in them at the fused joint.If too much pressure is applied near junction, the chamber will come apart.We wish to notify the manufacturer (fresenius) and request that these be glued or fused much tighter than their current state.

• Brand Name: CRIT-LINE®
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): FRESENIUS USA, INC.; 4040 nelson ave; concord CA 94520
• MDR Report Key: 15601951
• MDR Text Key: 301736567
• Report Number: 15601951
• Device Sequence Number: 1
• Product Code: KOC
• 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: 09/22/2022

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: CL10041021
• Device Catalogue Number: CL10041021
• Device Lot Number: 21JR01239
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1