MAUDE Adverse Event Report: SYNCARDIA SYSTEMS LLC SYNCARDIA - MOCK TANK; EXTERNAL PNEUMATIC DRIVER

Model Number SYNCARDIA MOCK TANK

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

Baylor dallas received a new mock tank on (b)(6) 2023 and it was setup by me ((b)(6)).The aop chamber started showing rust in the water within approximately 36 hours.They initially decided to keep that mock tank and just keep the water changed out frequently, however they now say the rust is getting worse and they want a replacement.

• Brand Name: SYNCARDIA - MOCK TANK
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS LLC; 1992 e silverlake rd; tucson, arizona
• Manufacturer (Section G): SYNCARDIA SYSTEMS LLC; 1992 e silverlake rd; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e silverlake rd; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17892451
• MDR Text Key: 326034855
• Report Number: 3003761017-2023-00115
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYNCARDIA MOCK TANK
• Device Lot Number: P/N C400600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention