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

Catalog Number 297004-001

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

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 tat-h in the event of a driver failure.This syncardia hand pump was not in patient use.The customer reported that the hand pump had a visible separation at the bottom of the housing between the two halves.The reported issue poses a low risk to a patient because the damage to the hand pump was observed when it was not in patient use.The hand pump will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).Not returned to manufacturer.

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 had a visible separation at the bottom of the housing between the two halves.The customer inadvertently sent the hand pump to (b)(6) instead of syncardia.Syncardia contacted the ventricular assist device (vad) coordinator at (b)(6) and requested that the hand pump s/n (b)(4) be shipped back for to syncardia for investigation.The vad coordinator at (b)(6) inspected the hand pump and could not find the reported issue of a visible separation at the bottom of the housing between the two halves and stated that the pump looked intact.The vad coordinator at (b)(6) decided to keep the hand pump.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: 4812371
• MDR Text Key: 5917263
• Report Number: 3003761017-2015-00176
• 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: Consumer,Health Professional,consumer,health profess
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 297004-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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