MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM POWER ADAPTOR; AC POWER ADAPTOR

Catalog Number 295070-001

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because it would not prevent the driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.The freedom power adaptor has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the power adaptor had a loose connection to the freedom driver supporting a patient.The black connector did not lock into place on the freedom driver.

Manufacturer Narrative

The freedom power adaptor was returned to syncardia for evaluation.The customer-reported issue of the power adaptor's output connector failing to securely latch into the driver's receptacle was verified by testing the p1 connector's latching function in two clinical freedom drivers.The p1 connector was unable to latch as designed.The cause for the power adaptor's p1 connector failure to latch into the freedom driver receptacle was that the p1 connector's latching spring was cracked, causing it to remain in the fully depressed position, thereby causing a malfunction to latch into the driver's receptacle.The root cause for the cracked connector latching spring is attributed to plastic fatigue associated with use wear because of multiple connector latch compression cycles.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, a syncardia certified hospital, reported that the power adaptor had a loose connection to the freedom driver supporting a patient.The black connector did not lock into place on the freedom driver.

• Brand Name: SYNCARDIA FREEDOM POWER ADAPTOR
• Type of Device: AC POWER ADAPTOR
• 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: 6582037
• MDR Text Key: 75862630
• Report Number: 3003761017-2017-00085
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2017
• 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 Age: 37 YR