Catalog Number 595000-001 |
Device Problems
Connection Problem (2900); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/30/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The customer reported that the red cpc connector (circular plastic connector) that is connected to the tah-t cannula was dislodged (mfr report #3003761017-2016-00289).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.The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.This alleged failure mode poses a low risk to the patient because although the spring on the cpc connector was dislodged, the freedom driver continued to perform its life-sustaining functions.The freedom driver 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.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 right 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) follow-up report 1.
|
|
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.(mfr report #3003761017-2016-00289).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.The customer also reported that the hospital staff replaced both cpc connectors when they switched the patient to a backup driver.
|
|
Search Alerts/Recalls
|