MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MARQUIS STOPCOCK; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 00884450007259

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Patient was a s/p (status post) right heart cath.Returned to the icu with a swan-ganz catheter.Connected to the distal port was a 3-way stopcock with vasopressin and levophed infusing.Patient progressively required higher doses of vasopressor therapy due to hemodynamic status.Staff noticed fluid leaking from back of stopcock.Patient was not receiving vasopressor medications appropriately.

• Brand Name: MARQUIS STOPCOCK
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 13093097
• MDR Text Key: 282838506
• Report Number: 13093097
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00884450007259
• Device Catalogue Number: M3RRC
• Device Lot Number: H2226882
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic