MAUDE Adverse Event Report: ICU MEDICAL TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number D1000

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Death (1802)

Event Date 01/06/2020

Event Type  Death  

Event Description

Continuous renal replacement therapy (crrt) in progress.Patient noted to be acutely bradycardic.Observed blood on the left side of the patient, patient found to be disconnected from crrt machine.Pressure was applied and catheters clamped, but heart rate continued to drop.Patient expired.The filter circuit on the patient return line found to be disconnected from the tego connector, which was attached to the patient's catheter.The disconnection occurred between the two products - the prismaflex set and the yellow tego connector.The tego connector attached to the vascath remained in place when the deceased was transferred for autopsy.The prismaflex circuit was sequestered and sent to the manufacturer for interrogation.The disconnection of the return line was not detectable, as the crrt default alarm parameters were not met.Suggested software enhancements for the manufacturer to explore: include incorporating rate/percentage based alarms for the return line.

• Brand Name: TEGO CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 9749953
• MDR Text Key: 180731186
• Report Number: 9749953
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: D1000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 24090 DA