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

Model Number	REVACLEAR 300
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upon initiation of dialysis a crack was noted in dialyzer.Unable to return blood to patient.Patient lost approximately 183cc of blood.Doctor was aware.

• Brand Name: REVACLEAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15216988
• Report Number: 15216988
• Device Sequence Number: 17709556
• Product Code: KDI
• UDI-Device Identifier: 07332414126193
• UDI-Public: (01)07332414126193
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/12/2022
• Report Date (Section F): 07/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: REVACLEAR 300
• Device Catalogue Number: 114745M
• Device Lot Number: C622305606
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 07/12/2022