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

Model Number 500101-001

Device Problems Contamination /Decontamination Problem (2895); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2020

Event Type  malfunction  

Manufacturer Narrative

The cpc connector is still supporting the patient and has not been returned to syncardia for evaluation.The customer reported that hospital personnel did not know how to change out a cpc connector so advanced training for the hospital personnel is being planned by the syncardia sales and clinical teams.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that when a patient's wife tried to switch her husband to a backup driver due to a fault alarm (mfr report # 3003761017-2020-00071), the metal part of the cpc connector would not push down or come apart.Therefore, it was decided that the patient needed to come to the hospital via ambulance to have the connection site assessed and be switched to a backup driver.The customer reported that when the patient arrived at the hospital, he was switched to a companion 2 driver.The customer also reported it was a bit difficult to detach the red driveline from the red cannula due to what seemed to be grainy material inside of the cpc connector.The customer reported that hospital personnel did not know how to replace the cpc connector but were able to force the cpc connector open and dislodge a grainy material from the connector.The customer also reported that the cpc connector subsequently worked fine after the grainy material was removed.No additional information on the grainy material is available at this time.

Manufacturer Narrative

Please disregard the initial report.The report was uploaded in error.Syncardia is closing this file.Ce 5205 follow-up report 1.

• 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
• MDR Report Key: 9759390
• MDR Text Key: 181547499
• Report Number: 3003761017-2020-00073
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 119223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR