MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problem Mechanical Problem (1384)

Patient Problem Hemolysis (1886)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver was causing hemolysis in a patient.Hospital personnel reported that the patient's ldh increased from 1000 iu/l to 2700 iu/l (upper limit of normal for hospital is 220 iu/l), plasma free hemoglobin increased from 20-30 mg/dl to 490 mg/dl (upper limit of normal for hospital is 30mg/dl) and urine was dark (which is indicative of hemolysis).The customer also reported that the patient was switched to the freedom driver.

Manufacturer Narrative

The customer-reported patient hemolysis caused by a possible device malfunction was unable to be confirmed.A device malfunction could not be reproduced during investigation testing using the patient simulator because the dmc tank contains water, not blood.The driver passed all functional testing and was subjected to an additional 72-hour observation run in an attempt to observe a possible malfunction or change in driver performance.The driver performed as intended, and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8277558
• MDR Text Key: 134089161
• Report Number: 3003761017-2019-00023
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/14/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR