MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX M 100 SET CRRT HEMOFILTER WITH TUBING; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number M 100S

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 05/03/2019

Event Type  malfunction  

Event Description

Crrt icu no.2 machine had air in the blood return line.Luckily, nurse was in the room and noticed the air.The crrt machine did not alarm or prevent the air from potentially reaching the pt.Clinical engineering worked with machine for 2 hours and found no problem.The machine is presently being stored in the office as out of service, until nurse mgr can further investigate.Tubing was also saved and in the office in a red biohazard bag.Fda safety report id# (b)(4).

• Brand Name: PRISMAFLEX M 100 SET CRRT HEMOFILTER WITH TUBING
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; meyzieu cedex 69883 FR; FR 69883 FR
• MDR Report Key: 8596850
• MDR Text Key: 144713350
• Report Number: MW5086496
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: 07332414064556
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: M 100S
• Device Lot Number: 18J3006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 126