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

Model Number M100

Device Problem Leak/Splash (1354)

Patient Problem Asystole (4442)

Event Date 09/05/2021

Event Type  Injury  

Event Description

This (b)(6) male was undergoing cwh therapy when the patient's ecmo pump stopped due to detecting an air bubble in the circuit.The patient became asystolic, cpr was initiated, and return of spontaneous circulation was achieved after one minute of chest compressions.Upon inspection of the ecmo circuit, it was noted the filter retained air bubbles that had to be evacuated, and the ecmo pump had to be restarted.The nursing team was able to reproduce this issue on four other sets from the same lot.Reference medsun # (b)(4).

• Brand Name: PRISMAFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES
• MDR Report Key: 12561921
• MDR Text Key: 274656596
• Report Number: MW5104322
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: M100
• Device Catalogue Number: 106697
• Device Lot Number: 21E2102
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 96