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

Catalog Number 502HF-RT

Device Problems Air Leak (1008); Crack (1135)

Patient Problem Air Embolism (1697)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

Account alleges that during a extracorporeal life support (ecls) therapy for a pediatric patient suffering from acute respiratory distress syndrome (ards).Air was introduced into the patient from the female lateral port of the manifold.The patient went into cardiac arrest and was resuscitated with a heart massage, adrenaline and advanced cardiac life support administration.The manifold was exchanged for a new one and the physician continued the therapy.The patient was placed back on extracorporeal circulation due to acute respiratory distress syndrome.The patients condition today is good but is still dependent on extracorporeal life support therapy.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A search of the complaint data base was performed and no similar complaints for this lot number were found.The complaint is not confirmed.The device history record was reviewed and no exception documents were found.

• 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: 6378675
• MDR Text Key: 69093123
• Report Number: 1721504-2017-00041
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K913161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 502HF-RT
• Device Lot Number: H1002272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2016
• 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: ADRENALINE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention