MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION DRIVELINE

Catalog Number C-400008-001

Device Problems Component Missing (2306); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/22/2014

Event Type  malfunction  

Event Description

These companion drivelines were not in use by a pt.The customer reported that when the companion drivelines were opened to the sterile field for use during an implant surgery of a syncarida temporary total artificial heart (tah-t), he observed that the companion drivelines did not have the full set of quick connectors (cpc connectors).The two quick connectors that insert into the tah-t cannulae (left and right) were not attached or included in the sterile double peel packed pouches.The surgeons used another set of companion drivelines from a surgical spares kit.This alleged failure mode poses a low risk to a pt, because the issue was observed before the companion drivelines were in use by a pt.An investigation will be conducted by syncardia, and the results will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

These companion drivelines were not in use by a patient.The customer reported that when the companion drivelines were opened to the sterile field for use during an implant surgery of a syncardia temporary total artificial heart (tah-t), he observed that the companion drivelines did not have the full set of quick connectors (cpc connectors).The two quick connectors that insert into the tah-t cannulae (left and right) were not attached or included in the sterile double peel packed pouches.The surgeons used another set of companion drivelines.Companion drivelines are manufactured by syncardia's oem supplier, (b)(4).An investigation was conducted by (b)(4).Review of the (b)(4) complaint, non-conforming and corrective action databases for similar issues revealed that there has been one other similar occurrence reported to date.A review of the device history record and associated documentation for p/n: 0252-06375: (b)(4) indicates that the product met the specified requirements prior to release to the customer.Since this lot was produced, six additional lots of product have been produced consisting of (b)(4) drivelines with no reported similar issues.This alleged failure mode poses a low risk to a patient, because the issue was observed before the companion drivelines were in use by a patient.In addition spare companion drivelines are supplied to the customer.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 COMPANION DRIVELINE
• Type of Device: DRIVELINE
• 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: 3907030
• MDR Text Key: 4650347
• Report Number: 3003761017-2014-00037
• 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: Company Representative,company representative,hea
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: C-400008-001
• Device Lot Number: 18469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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