MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	300
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Revaclear dialyzer had black spots floating in the chamber.

• Brand Name: REVACLEAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; 32650 n. wilson rd.; round lake IL 60073
• MDR Report Key: 7369414
• Report Number: 7369414
• Device Sequence Number: 1094198
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: (01)07332414114916
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2018
• Report Date (Section F): 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: 300
• Device Catalogue Number: 114745
• Device Lot Number: 7-9270-H-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2018
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/12/2018