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

Catalog Number 500101

Device Problems Air Leak (1008); Material Discolored (1170); Material Too Rigid or Stiff (1544); Material Rupture (1546); Device Displays Incorrect Message (2591)

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

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00129), freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00130), and 70cc tah-t cannula s/n (b)(4)(mfr report # 3003761017-2016-00131).On (b)(6) 2016, the customer reported that the freedom driver s/n (b)(4) exhibited a fault alarm while supporting a patient.The customer also reported that the patient was sedentary and had 2 fully charged onboard batteries in the driver during the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver.The customer also reported that there was a significant amount of air leaking out of the 70cc temporary total artificial heart (tah-t) red cannula s/n (b)(4).The customer also reported that the tear "was circular, about half of the cannula and it was about 0.5cm above the white connector." the customer also reported that the 70cc tah-t cannulae were discolored and stiff.The customer also reported that the patient applied rescue tape at home to prevent cardiac output (co) loss and another fault alarm.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff when the patient was taken to the hospital.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.The customer also reported that upon the patient's arrival to the hospital, it was noted that the freedom ac power supply cord s/n (b)(4) is starting to fray.The patient was provided with a replacement ac power supply.The 70cc tah-t cannula s/n (b)(4) will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).Hospital cannot locate damaged cannula.

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: primary freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00129), freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2016-00130), and 70cc tah-t cannula s/n (b)(4) (mfr report # 3003761017-2016-00131).On (b)(6) 2016, the customer reported that the freedom driver s/n (b)(4) exhibited a fault alarm while supporting a patient.The customer also reported that the patient was sedentary and had 2 fully charged onboard batteries in the driver during the reported event.The customer also reported that the patient was subsequently switched to the backup freedom driver.The customer also reported that there was a significant amount of air leaking out of the 70cc temporary total artificial heart (tah-t) red cannula s/n (b)(4).The customer also reported that the tear "was circular, about half of the cannula and it was about 0.5cm above the white connector." the customer also reported that the 70cc tah-t cannulae were discolored and stiff.The customer also reported that the patient applied rescue tape at home to prevent cardiac output (co) loss and another fault alarm.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff when the patient was taken to the hospital.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.The customer also reported that upon the patient's arrival to the hospital, it was noted that the freedom ac power supply cord s/n (b)(4) is starting to fray.The patient was provided with a replacement ac power supply.The damaged section of the 70cc tah-t cannula s/n (b)(4) was not returned to syncardia for investigation since the customer disposed of the damaged section of cannula.A review of the device history record (dhr) for the, ventricle shop orders, cannula assembly shop orders, and the sterilization work order for the 70cc tah-t s/n (b)(4) confirmed that all manufacturing was performed to specifications and the 70cc tah-t met all specified requirements prior to shipment.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.Per the syncardia freedom driver system guidebook for patients and caregivers - us, end users are instructed to inspect the drivelines and cannulae daily.If a hole is observed in the drivelines or cannulae, household tape must be applied to temporarily repair the hole and the hospital contact person must be contacted to arrange for a hospital-based evaluation.

• Brand Name: SYNCARDIA 70CC TAH-T CANNULA
• 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: 5563818
• MDR Text Key: 42947276
• Report Number: 3003761017-2016-00131
• 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: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR