MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA HAND PUMP

Catalog Number 397004-001

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

This syncardia hand pump was not in pt 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 hand pump "has something loose inside and can be heard when the pump is turned upside down or shaken".This alleged failure mode poses a low risk to a pt because the damage to the hand pump was observed when it was not in use on a pt.The hand pump will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This 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 hand pump "has something loose inside and can be heard when the pump is turned upside down or shaken".The hand pump was returned to syncardia for evaluation.Visual inspection of the exterior of the hand pump revealed cracked housings.The hand pump met all function test acceptance criteria except for the housing alignment because of the cracked housings.Visual inspection of the hand pump's internal components revealed: a removed pem nut and a broken pem nut boss on the right interior housing; a removed pem nut from the piston mounting bracket.The broken pem nut boss confirmed the loose internal part heard by the customer.The root cause for the customer reported issue is known to be the result of the hand pump experiencing an impact shock, which is also evidenced by the cracked housing.Despite the damage to the hand pump, the hand pump passed all pressure and cardiac output testing performed during failure investigation and functioned as intended.The hand pump was not in use on a patient at the time of the customer reported issue.However, had the hand pump been in patient use, the hand pump would have performed as intended and would been able to provide adequate cardiac output until the patient was switched to a backup driver.The hand pump was taken out of service.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 HAND PUMP
• Type of Device: HAND PUMP
• 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: 4008473
• MDR Text Key: 15364148
• Report Number: 3003761017-2014-00100
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 397004-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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