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

Model Number 300

Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 02/01/2018

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 100153620
• Report Number: 7273057
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: (01)07332414114916
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 231