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	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was on a continuous renal replacement therapy (crrt) for acute kidney injury after cardiac arrest.Registered nurse (rn) noted leaking of fluid from system.This tubing was not saved but stock of same lot # was removed from supply.Lot # 23a0094ca.Crrt tubing routed through effluent pump came disconnected from the line routing through the auto-effluent pump.The drip chamber wet alarm was sounding.Tubing inspection post removal from the crrt pump was found completely loose.Lot# 23a0056cd.No harm to patient at either time.Back stock of this lot number also pulled from supply.Manufacturer response for dialyzer, high permeability with or without sealed dialysate system, prismaflex set (per site reporter).Manufacturer would like it returned to them for examination.

• 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; round lake IL 60073
• MDR Report Key: 18475760
• Report Number: 18475760
• Device Sequence Number: 6784822
• 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): 11/08/2023
• Report Date (Section F): 11/08/2023

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
• Device Model Number: M150
• Device Catalogue Number: 109990
• Device Lot Number: 23A0056CD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• 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: Male
• Patient Weight: 98 KG
• Patient Race: White
• Date Report Sent to FDA: 11/08/2023