MAUDE Adverse Event Report: LIVA NOVA CENTRIFUGAL PUMP; CONTROL, PUMP SPEED, CARDIOPULMONARY

Model Number F80761

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 03/08/2019

Event Type  Injury  

Event Description

Per report: pt on ecmo, pump was turned up to 3500 to support pt, loud grinding noise was heard and the pump vibrated.The flow reading went to 0.The pump head was removed and placed on hand crank.Ecmo specialist hand cranked and supported pt until perfusionist arrived.Brought in backup pump, stopped hand cranking and changed pump head to backup.Fda safety report id# (b)(4).

• Brand Name: CENTRIFUGAL PUMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY
• Manufacturer (Section D): LIVA NOVA; london ; UK
• MDR Report Key: 8619955
• MDR Text Key: 145495791
• Report Number: MW5086706
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F80761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 98