MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 300

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

The dialyzer has many fibers.During dialysis, as the rinse was occurring, a foreign particle was noted on the outside of the fibers.

• Brand Name: REVACLEAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, INC.; 14143 denver w pkwy; lakewood CO 80401
• MDR Report Key: 12614515
• MDR Text Key: 275916306
• Report Number: 12614515
• Device Sequence Number: 1
• Product Code: KDI
• 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: 10/07/2021

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: Health Professional
• Device Model Number: 300
• Device Catalogue Number: 114745L
• Device Lot Number: C621304206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 54