MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited an abnormal waveform while supporting a patient.The patient subsequently had an acute kidney injury.The customer also reported that the patient was subsequently switched to a freedom driver.

Manufacturer Narrative

The driver was returned because of a steep rise on the right pressure waveform.This issue was confirmed by reviewing the customer provided documentation and was reproduced during functional testing.Although the waveform was observed to be steep, syncardia has no set criteria or tolerance window for the steepness of this waveform.Investigation testing determined the reported issue was caused by a malfunction of the right electronic pressure regulator.Syncardia has a corrective and preventative action plan (capa) to address electronic pressure regulators causing irregular pressure waveforms.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• MDR Report Key: 9935674
• MDR Text Key: 187452067
• Report Number: 3003761017-2020-00099
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR