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

Model Number M100

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 09/05/2021

Event Type  Injury  

Event Description

"crrt set was changed and restarted and patient immediately shut ecmo pump off.Ecmo pump read, "air bubble detected." patient became bradycardic and then asystolic.Cpr started which lasted ~1 min.Return of spontaneous circulation achieved.Crrt terminated at this time." per nursing and ecmo team, the filter has more air bubbles in these sets than normal.

• Brand Name: PRISMAFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12540516
• MDR Text Key: 273652145
• Report Number: 12540516
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556
• 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: 09/10/2021

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 Operator: Health Professional
• Device Model Number: M100
• Device Catalogue Number: 106697
• Device Lot Number: 21E2102
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 13870 DA
• Patient Weight: 97