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

Catalog Number 397004-001

Device Problems Crack (1135); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2016

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 the hand pump has a cracked housing.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

(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 hand pump had a cracked housing.The hand pump was returned to syncardia for evaluation.Visual inspection of the exterior components revealed a crack in the right side housing, and the left and right side housings were slightly separated.Visual inspection of the interior revealed three dislodged swage nuts from the corresponding standoffs.The damage was likely caused by an impact shock.The hand pump was functionally tested and met the functional requirements for pressure and cardiac output.Because of the damage to the housing, the hand pump was returned to the supplier for repair.In accordance with the "syncardia hand pump operator manual," if the hand pump is dropped or damaged, it should be returned to syncardia.The reported issue posed a low risk to a patient because the damage to the hand pump was observed when it was not in use on a patient.In addition, the damage to the hand pump would not have prevented it from performing its life-sustaining functions.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: 5579988
• MDR Text Key: 43547246
• Report Number: 3003761017-2016-00149
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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: Other Health Care Professional
• Device Catalogue Number: 397004-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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