MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET

Model Number MX4345LM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/01/2017

Event Type  malfunction  

Event Description

Cardiovascular icu patient was on multiple pressor medications running through a 5 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) 70's,60's,50's over a 15 minute time.Rn increased pressor doses by significant amounts.Patient was also on continuous renal replacement therapy (crrt) so some rescue fluid was infused and peak flow rate (pfr) 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.Md was made aware and intensivist md was made aware and both came to bedside.Neo bolus was given by intensivist md.Rn double checked infusing lines and found none of the pressor medications were infusing into pt but, instead, were wetting the bed.The 5 gang stopcock became stripped and broke off single stopcock attached to introducer side arm.There was no blood return with disconnection from introducer.

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• MDR Report Key: 6593619
• MDR Text Key: 76038998
• Report Number: 6593619
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX4345LM
• Device Catalogue Number: MX4345LM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.
• Patient Age: 57 YR