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

Catalog Number 500101

Device Problems Air Leak (1008); Material Discolored (1170); Material Too Rigid or Stiff (1544); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components: tah-t cannulae - s/n (b)(4)-ct (mfr report #3003761017- 2016-00068) and tah-t cpc connector - s/n (b)(4)-ct (mfr report #3003761017-2015-00070).The customer reported that the tah-t cannulae are discolored and rigid.The customer also reported that the hospital staff member noticed that the spring on the tah-t cpc connector was dislodged and there was an air leak.The tah-t cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer also reported that the physician was able to push the spring back on the tah-t cpc connector, however the air leak did not resolve.The customer also reported that the tah-t cpc connector was successfully repaired by the physician.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because the discolored and rigid cannulae and cpc connector air leak did not prevent the tah-t and freedom driver from performing their life-sustaining functions.The removed tah-t cannula piece and tah-t cpc connector will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

Corrected to syncardia 70cc temporary total artificial heart (tah-t).(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components: tah-t cannulae - s/n (b)(4) (mfr report #3003761017- 2016-00068) and tah-t cpc connector - s/n (b)(4) (mfr report #3003761017-2015-00070).The customer reported that a hospital staff member noticed that the spring on the tah-t cpc connector was dislodged and there was an air leak.The tah-t cpc connector is a component that provides the interface between the drivelines and the tah-t cannulae.The customer also reported that the physician was able to push the spring back on the tah-t cpc connector; however, the air leak did not resolve.The customer also reported that the cpc connector was successfully replaced by the physician.There was no reported adverse patient impact.The cpc connector with attached section of cannula was returned to syncardia for evaluation.Visual inspection of the spring under the thumb release tab revealed that it was in the correct position and had no apparent damage.During investigation testing, the returned cpc connector (female end) was mated with a male connector fixed to an inert gas source, and a new piece of cannula was connected to the returned female end.The distal end was closed off to pressurize the cpc junction, and no air leak was heard.Then a liquid leak detector was applied around the cpc connector junction, and there was no indication of an air leak.The reported issue of an air leak was not able to be reproduced during investigation testing.The patient was successfully transplanted on (b)(6) 2016.The reported issue of an air leak at the cpc connector posed a low risk to the patient because it did not prevent the tah-t and freedom driver from performing their life-sustaining functions.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.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5451049
• MDR Text Key: 39209617
• Report Number: 3003761017-2016-00070
• 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: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 500101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2012
• 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: 59 YR