MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Anxiety (2328)

Event Date 07/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient noticed the red cpc connector (circular plastic connector) that is connected to the tah-t cannula was dislodged and the patient was anxious to switch to a backup driver.The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer also reported that the hospital staff noticed the spring on the blue cpc connector (circular plastic connector) that is connected to the freedom driver was also dislodged.The dislodged spring is located on the right side driveline female cpc connector of the driver (mfr report #3003761017-2016-00286).The customer also reported that the hospital staff replaced both cpc connectors when they switched the patient to a backup driver.This alleged failure mode poses a low risk to the patient because although the spring on the cpc connector was dislodged, the tah-t system continued to perform its life-sustaining functions.The cpc connector will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

First paragraph was corrected to indicate that the spring in the red cpc connector was dislodged and not the cpc connector itself.Implant date corrected to (b)(6) 2015.The cpc connector was returned to syncardia for evaluation.The results of the visual inspection of the cpc connector aligned with the description in the customer-reported issue.There was a dislodged spring in the left female cpc connector, confirming the customer-reported issue.It cannot be conclusively determined how the spring was dislodged within the cpc connector.However, the most likely root cause based on the available evidence is that it was dislodged during a driver switch out event.The spring dislodgement noted in this investigation was consistent with a known malfunction mode previously documented.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.(b)(4).

Event Description

The customer reported that the patient noticed the spring in the red cpc connector (circular plastic connector) that is connected to the tah-t cannula was dislodged and the patient was anxious to switch to a backup driver.The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer also reported that the hospital staff noticed the spring in the blue cpc connector (circular plastic connector) that is connected to the freedom driver was also dislodged.The dislodged spring is located in the right side driveline female cpc connector of the driver.(mfr report #3003761017-2016-00286).The customer also reported that the hospital staff replaced both cpc connectors when they switched the patient to a backup driver.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5893642
• MDR Text Key: 53670984
• Report Number: 3003761017-2016-00289
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 500101
• Device Lot Number: 096913-CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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: 54 YR