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

Catalog Number 397004-001

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

Thi syncardia hand pump was not in pt use.The customer reported that the hand pump is an accessory to the companion 2 drive 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.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 evaluation.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 customer reported that the hand pump is missing an o ring and that the o ring had "rotted off." 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 hand pump was returned to syncardia for evaluation.Visual inspection of the exterior of the hand pump revealed a cracked housing on the front and rear top edges, and a rattling noise was emanating from the inside of the unit while the unit was turned over during inspection.The only o-ring visible from the exterior is the cpc connector o-ring located on the front of the unit.The cpc o-ring was found to be in place but was cracked.Therefore, the customer reported missing o-ring was not confirmed and no fault was found in relation to the customer reported issue.Visual inspection of the hand pump's interior revealed loose broken plastic pieces originating from the interior of the housing, a broken pem nut boss, and a bent connector mounting bracket.Although not reported by the customer, it is likely that the cumulative damage found on hand pump was the result of an impact shock.The device was not in use with a patient at the time of the customer reported issue.Despite the customer reported issue of a missing o-ring, which was not confirmed, and cracked housings, the hand pump met all pressure and cardiac output test requirements and functioned as intended.Therefore, risk to a patient is low should there have been a need to use the hand pump.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 Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4368378
• MDR Text Key: 5288459
• Report Number: 3003761017-2014-00315
• 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,Followup
• Report Date: 12/15/2014

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: Other Health Care Professional
• Device Catalogue Number: 397004-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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