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.

Manufacturer Narrative

Other, other text: the device was not returned; however, from the picture provided it appears as though the tubing pulled from the luer connector.The tubing and luer connectors are mated together with the use of solvent to bond them together.Parts are tested by the operators per procedure.Parts are to be tested every hour.Parts are also 100 percent inspected for gaps between the end of the tubing and the end of the luer.This check is in place to identify parts assembled without the proper level of solvent (due to potential air bubbles etc in solvent lines).If parts are found with a gap the lot is written up for an ncmr and sorted.On top of this qc inspectors checked pull tests on the overall lot with a c equals 0 inspection and an aql of 4.00 percent.Without the lot number we are unable to confirm the values of the tested parts during the run of this lot of tubing sets.

Event Description

Additional information was provided detailing that no acls meds were given.The patient's vitals normalized after ecmo flows were restored.

• Brand Name: MEDEX
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 11052031
• MDR Text Key: 223046979
• Report Number: 3012307300-2020-12637
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10351688506597
• UDI-Public: 10351688506597
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention