MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 595000-001

Device Problems Material Discolored (1170); Material Too Rigid or Stiff (1544)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2015

Event Type  malfunction  

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components: tah-t - l/n 078127 (mfr report #3003761017-2015-00084) and freedom driver - s/n (b)(4).The pt was implanted with the tah-t on (b)(6) 2014, supported by a syncardia companion 2 driver.On (b)(6) 2014, he was switched to a portable freedom driver.On (b)(6) 2015, the customer reported that the pt's tah-t cannulae and freedom driver drivelines were "black and stiff".The customer also reported that the pt said that his cannulae and drivelines had been discolored for at least four months.The customer also reported that the pt's home health care nurse had given the pt "some kind of wipe" to clean off his cannulae and drivelines.

Manufacturer Narrative

On (b)(6) 2015, the pt switched to a backup freedom driver without adverse impact.This alleged failure mode poses a low risk to the pt because it did not prevent the tah-t and freedom driver from performing their life-sustaining functions.Freedom driver (b)(4) and attached drivelines will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4) follow-up report 1.

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components: tah-t - l/n 078127 (mfr report #3003761017- 2015-00084) and freedom driver - s/n (b)(4) (mfr report #3003761017-2015-00085).The patient was implanted with the tah-t on (b)(6) 2014, supported by a syncardia companion 2 driver.On (b)(6) 2014, he was switched to a portable freedom driver s/n (b)(4).On (b)(6) 2015, the customer reported that the patient's tah-t cannulae and freedom driver drivelines were "black and stiff." the customer also reported that the patient said that his cannulae and drivelines had been discolored for at least four months.The customer also reported that the patient's home health care nurse had given the patient "some kind of wipe" to clean off his cannulae and drivelines.The customer also reported the following: on (b)(6) 2015 the patient was switched to a backup freedom driver without adverse impact.Later that day, the patient's cannulae were repaired by cutting off the blackened sections of cannulae, and new sections of cannulae were connected with quick (cpc) connectors.The customer also reported that there was no adverse impact on the patient as a result of the cannulae repair.Freedom driver s/n (b)(4) and driveline were returned to syncardia for evaluation.Evaluation of the cannulae and drivelines at syncardia indicated that the cause of the discoloration was likely from exposure to a product in the patient's environment or a product that was applied topically to the cannulae and drivelines.The colored tape applied to the cpc connector end of the drivelines protected the tubing from being exposed to the source of discoloration.The customer reported that the patient was given wipes by his home health care nurse to clean the cannulae and drivelines.Intertek is a syncardia approved level 3 supplier that provides analytical testing services.Evaluation of the cannulae and drivelines by intertek indicated that the discolored cannulae experienced a significant loss of plasticizers, from 45% plasticizers in unused cannulae to 30% plasticizers in the discolored cannula.There was an increase in concentrations of silicon, sulfur, calcium and potassium in discolored cannula compared to unused cannula.This was indicative of less plasticizer in the darkened cannula, which would make the cannula material more brittle, as noted by the customer experience.In addition, the intertek analysis indicated that the discolored cannula contained bromine, while the unused cannula had none.Hospital personnel, caregivers or the patient could have wiped the cannulae and drivelines with a cleaning product that contained bromine.This external cleaning product could have removed plasticizer in the cannula and caused bromine to appear in the chemical composition of the cannula.Bromine has a brownish color.Per syncardia's freedom driver system guidebook for patients and caregivers - us, section 9.1.2, users are instructed to inspect the drivelines and cannulae daily, and the drivelines are to be cleaned with a soft, clean cloth lightly dampened with mild soap and water solution.The investigation could not definitively determine the source of the customer-reported discoloration.(b)(4).There was no reported permanent impact on the patient as a result of the cannulae/driveline discoloration or subsequent repair.Freedom driver s/n (b)(4) was serviced and passed all functional and performance testing before being placed into finished goods.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 FREEDOM DRIVER
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): 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: 4613108
• MDR Text Key: 5653252
• Report Number: 3003761017-2015-00085
• 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 Facility,health professional,use
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 18 YR