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

Catalog Number 500101

Device Problems Moisture Damage (1405); Failure to Align (2522); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problems Syncope (1610); Dizziness (2194); Loss of consciousness (2418)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

The cpc connector will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2017-00082 and 70cc tah-t l/n 101770 cpc connector (mfr report # 3003761017-2017-00083).The customer, a syncardia certified hospital, reported that as the patient reached out, his freedom driver turned over into the sink which had the faucet running and began to exhibit fault alarms after getting wet.The customer also reported that as the patient and friend prepared for a driver switch, the patient was unable to depress and release the left ventricle cpc connector due to a misaligned spring.The customer also reported that while the patient worked to release the cpc connector, the alarming freedom driver stopped and the patient became unconscious for approximately 10-15 seconds.The friend was able to release the cpc connector and successfully switched the patient to the backup freedom driver.Once connected, the patient regained consciousness.The customer also reported that the patient denied any headaches and stated he had some dizziness on the way to hospital but was resolved.The customer also reported that the cpc connector was replaced at the hospital and the patient tolerated the change well.

Manufacturer Narrative

The cpc connector was returned to syncardia for evaluation.The results of the visual inspection of the cpc connector aligned with the description of the customer-reported event.The left female cpc connector spring was missing and there was minor damage to the plastic housing consistent with difficult disconnection.It cannot be conclusively determined when the spring became displaced within the housing, and how the spring became dislodged from the cpc connector.However, the most likely root cause based on the available evidence is that the spring was displaced/became misaligned after a previous driver switch out or during the driver switch (removal of the wire tie) described in the customer-reported issue.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 reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) freedom driver s/n (b)(4) (mfr report # 3003761017-2017-00082 and (2) 70cc tah-t l/n 101770 cpc connector (mfr report # 3003761017-2017-00083).The customer, a syncardia certified hospital, reported that as the patient reached out, his freedom driver turned over into the sink which had the faucet running and began to exhibit fault alarms after getting wet.The customer also reported that as the patient and friend prepared for a driver switch, the patient was unable to depress and release the left ventricle cpc connector due to a misaligned spring.The customer also reported that while the patient worked to release the cpc connector, the alarming freedom driver stopped and the patient became unconscious for approximately 10-15 seconds.The friend was able to release the cpc connector and successfully switched the patient to the backup freedom driver.Once connected, the patient regained consciousness.The customer also reported that the patient denied any headaches and stated he had some dizziness on the way to hospital but was resolved.The customer also reported that the cpc connector was replaced at the hospital and the patient tolerated the change well.

Manufacturer Narrative

Corrected data: corrected to serious injury.(b)(4).Follow-up report 2.

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) freedom driver s/n (b)(4) (mfr report # 3003761017-2017-00082 and (2) 70cc tah-t l/n 101770 cpc connector (mfr report # 3003761017-2017-00083).The customer, a syncardia certified hospital, reported that as the patient reached out, his freedom driver turned over into the sink which had the faucet running and began to exhibit fault alarms after getting wet.The customer also reported that as the patient and friend prepared for a driver switch, the patient was unable to depress and release the left ventricle cpc connector due to a misaligned spring.The customer also reported that while the patient worked to release the cpc connector, the alarming freedom driver stopped and the patient became unconscious for approximately 10-15 seconds.The friend was able to release the cpc connector and successfully switched the patient to the backup freedom driver.Once connected, the patient regained consciousness.The customer also reported that the patient denied any headaches and stated he had some dizziness on the way to hospital but was resolved.The customer also reported that the cpc connector was replaced at the hospital and the patient tolerated the change well.

• 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: 6567284
• MDR Text Key: 75324896
• Report Number: 3003761017-2017-00083
• 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,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 500101
• Device Lot Number: 101770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: Not provided; 06/08/2017
• Supplement Dates FDA Received: 06/20/2017; 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR