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

Catalog Number 397004-001

Device Problems Break (1069); Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(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 there are loose parts inside the hand pump.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.

Manufacturer Narrative

The hand pump was returned to syncardia for evaluation.Visual inspection of the hand pump's exterior revealed the following observations: o left side housing chip.O right side housing crack.O two broken swage nut standoffs.O two dislodged swage nuts.O the right side driveline tubing was kinked.The hand pump did not pass the acceptance criteria for housing alignment; however, the hand pump did meet the functional requirements for tank pressures and cardiac output.Based on the visual inspection observations, the most likely root cause for the customer-reported experience is impact shock.Although no specific loose parts were identified in this investigation, it is possible that as a result of the improper handling of the hand pump, the customer heard broken pieces related to the observed damage of the housing interior or misplaced screws.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.Ce 3486 follow-up report 1.

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 there are loose parts inside the hand pump.

• 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: 5918209
• MDR Text Key: 54345692
• Report Number: 3003761017-2016-00309
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2012
• 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