MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA HAND PUMP

Catalog Number 397004-001

Device Problems Crack (1135); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the damage to the hand pump was observed when it was not in use on a patient.The hand pump will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The syncardia hand pump was not in patient use.The syncardia hand pump is an accessory to the companion 2 driver system.The hand pump is designed to provide manual short-term emergency support of the syncardia tah-t in the event of a driver failure.The customer reported that the housing is cracked.The customer also reported that there is difficulty in getting the cardiac output (co) above 3.0 lpm.

Manufacturer Narrative

The hand pump was returned to syncardia for evaluation.Visual inspection of the hand pump's exterior components revealed cracked housings, a missing colder connector o-ring and missing rubber foot.Internal inspection of the hand pump and subsequently the piston cylinder identified damage to one of the check valves for the top chamber.The damage is consistent with a foreign object from the broken housings falling into the piston cylinder.When manual pumping was initiated, the foreign object made contact with the check valve and broke the internal workings of the check valve rendering it inoperable.The investigation revealed evidence of improper handling and/or impact shock, which is the likely root cause of 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).

Event Description

The syncardia hand pump was not in patient use.The syncardia hand pump is an accessory to the companion 2 driver system.The hand pump is designed to provide manual short-term emergency support of the syncardia tah-t in the event of a driver failure.The customer reported that the housing is cracked.The customer also reported that there is difficulty in getting the cardiac output (co) above 3.0 lpm.

• Brand Name: SYNCARDIA HAND PUMP
• Type of Device: HAND PUMP
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6057318
• MDR Text Key: 58774121
• Report Number: 3003761017-2016-00346
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

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: Health Professional
• Device Catalogue Number: 397004-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1