MAUDE Adverse Event Report: TRANSONIC SYSTEMS INC. TRANSONIC; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number HT110

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

No low flow alarms triggered by r ij ecmo flow probe.Alarm issues: alarm set incorrectly.Prior to event, stable r ij ecmo flows >1.3 and stable l groin ecmo > 4.4 noted during morning handoff report with pm rn and during "pre-rounds" with ald resident.Around 0845 - no flow on r ij ecmo cannula visually noticed with anesthesiologist during icu rounds, no alarms at this time.Perfusionist assessed and reported seeing separation of blood/clot in r ij cannula.Patient has a known atrial septal defect (asd).Throughout the event patient was hemodynamically stable and intact mental status.Emergent removal of r ij cannula performed bedside by md.Patient received 30mcg epinephrine iv push for cardiac support and 125mcg of fentanyl.Patient hemodynamically tolerated the decannulation.Low flow alarm or no flow alarm would have been useful in this situation.

• Brand Name: TRANSONIC
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): TRANSONIC SYSTEMS INC.; 34 dutch mill rd; ithaca NY 14850
• MDR Report Key: 11789671
• MDR Text Key: 249459282
• Report Number: 11789671
• Device Sequence Number: 1
• Product Code: DPW
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HT110
• Device Catalogue Number: UNKNOWN
• Device Lot Number: HT110
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Weight: 41