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 Code Available (3191)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Dialysis initiated with no problems.Ran for 20 minutes and blood clotted in the dialyzer and venous chamber.Blood returned new set up on the machine.Again dialysis resumed with no problems with patient or machine.Twenty five minutes into treatment venous pressure alarm on machine alarmed.Venous pressure was at 300.Flushed lines and venous pressures decreased the suddenly increased to 840.At the same time a blood leak alarm occurred.Visible blood noted in the venous (blue) dialysate line.Blood not returned.

• Brand Name: REVACLEAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; 1101 jeter avenue; opelika AL 36801
• MDR Report Key: 7273057
• Report Number: 7273057
• Device Sequence Number: 1043957
• 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): 02/07/2018
• Report Date (Section F): 02/07/2018

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: 07/31/2020
• Device Model Number: 300
• Device Catalogue Number: 114745
• Device Lot Number: 7-9863-H-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2018
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 231
• Date Report Sent to FDA: 02/07/2018