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

Catalog Number MX4345LM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bradycardia (1751)

Event Date 05/01/2017

Event Type  Injury  

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 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
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial monterrey; apodaca, nl CP 66 603; MX CP 66603
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6674914
• MDR Text Key: 78654891
• Report Number: 3012307300-2017-01386
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507594
• UDI-Public: 10351688507594
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX4345LM
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• 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): Required Intervention
• Patient Age: 57 YR