MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC MERIT MANIFOLD

Catalog Number 205BF-FT

Device Problem Crack (1135)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A search of the complaint database and device history record could not be performed since the lot number was not provided.

Event Description

The account alleged there was a crack in the manifold while administering medications post procedure in the intensive care unit.A leak was noticed where the crack was located and the medications were no longer infusing correctly.The patient suffered severe hypotension and required acls medications to prevent cardiac arrest.

• Brand Name: MERIT MANIFOLD
• Type of Device: MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6377230
• MDR Text Key: 69048851
• Report Number: 1721504-2017-00038
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 205BF-FT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• 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: Initial
• Patient Sequence Number: 1
• Treatment: BICARB DRIP; EPINEPHRINE; LEVOPHED; VASOPRESSIN
• Patient Outcome(s): Life Threatening; Required Intervention