MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK; STOPCOCK, I.V. SET

Catalog Number	MX4345LM
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that pressor medication stopped infusing during use of a medex¿ large bore - hi-flo¿ stopcock.The cardiovascular icu patient was on multiple pressor medications running through a five gang stopcock setup connected to an introducer side arm via another single stopcock attachment.The patient, immediately after being turned, became acutely hypotensive: systolic blood pressure (sbp) fell from 70s to 50s over a 15 minute time frame.The nurse increased pressor doses by significant amounts.The patient was also on continuous renal replacement therapy (crrt), and rescue fluid was infused and peak flow rate turned to 0.Patient was being a-paced with temporary pacemaker up to a rate of 90 and iabp advance from 1:2 to 1:1, all with little to no effect.The patient's doctor and intensivist doctor was made aware and both came to the patient's bedside.Neo bolus was given by the intensivist doctor.The nurse double checked infusing lines and found that none of the pressor medications were infusing.Into the patient, but instead, or wetting the bed.The five gang stopcock became stripped and broke off.The single stopcock attached to the introducer side arm.There was no blood return with disconnection from introducer.It was then observed that the threads of the single stopcock did not engage deeply enough with the threads of the manifold's luer lock, and could easily be twisted past the tightest point and then become loose again.There were no apparent cracks that would cause the luer lock to act this way.The original intended procedure was using the manifold to deliver medication from multiple iv pumps.No permanent injury was reported.

• Brand Name: MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6674914
• Report Number: 3012307300-2017-01386
• Device Sequence Number: 72151
• Product Code: FMG
• UDI-Device Identifier: 10351688507594
• UDI-Public: 10351688507594
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX4345LM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR