MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MX560

Device Problem Break (1069)

Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant therapy: ecmo machine.

Event Description

Information was received indicating that a smiths medical tubing pigtail broke off at the crrt access site (pre stopcock) while hoisting the patient up in the bed.There was no noticed stretching of the plastic to make the tubing break.The pigtail was shooting blood out of the ecmo circuit onto the bed and floor.It was clamped off to stop bleeding.A new pigtail and stopcock were primed to resolve the events.Patient was clamped off ecmo for 20 seconds while a new pigtail was placed.Patient became bradycardic into the 30's, and hypertensive.There were no other adverse events reported.

• Brand Name: MEDEX
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11049782
• MDR Text Key: 223048155
• Report Number: 3012307300-2020-12626
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10351688506597
• UDI-Public: 10351688506597
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention