MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC. SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number P/N 500101

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

If the section of damaged cannula is removed and replaced, it has been ask to be returned to syncardia for evaluation.Those results will be provided in a follow-up mdr.

Event Description

The customer, a syncardia authorized distributor, reported that the patient had a tear on one cannula line.The cannula was reviewed by clinical support to be a single thickness tear, and there was no air leaking from the cannula.Clinical support sent sections of cannula to the distributor for them to evaluate a possible replacement of the torn section of cannula.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713
• MDR Report Key: 16743357
• MDR Text Key: 313728038
• Report Number: 3003761017-2023-00044
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 500101
• Device Lot Number: 125574
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male