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

Model Number REVACLEAR 300

Device Problems Crack (1135); No Flow (2991)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/05/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 297797231
• Report Number: 15216988
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414126193
• UDI-Public: (01)07332414126193
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 07/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3285 DA
• Patient Sex: Female