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

Model Number	M150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was receiving continuous venovenous hemodiafiltration (cvvhdf) and the continuous renal replacement therapy (crrt) with the prisma flex machine shut down with screen message saying call service, system failure and discontinue treatment.Immediately, the registered nurse (rn) followed the instructions on the screen and returned patient's blood and disconnected the patient from the machine.A picture of the screen message was taken and biomed called and shown the message.Biomed checked the crrt machine and it was operating properly and biomed called baxter to discuss the message.Baxter informed biomed the issue could be a pressure pod or the crrt cassette.The pressure pods were checked and operating properly so the crrt cassette with m-150 assumed to be the issue.The rn changed the prisma flex machine and loaded a new cassette which takes at least 20 minutes to prime.

• Brand Name: PRISMAFLEX SET
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; 25212 w. il route 120; rlt-10; round lake IL 60073
• MDR Report Key: 19049745
• Report Number: 19049745
• Device Sequence Number: 7242265
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2024
• Report Date (Section F): 03/13/2024

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: M150
• Device Catalogue Number: 109990
• Device Lot Number: 23E0078CB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• 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: Unknown
• Date Report Sent to FDA: 03/13/2024