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

Catalog Number 397004-001

Device Problems Break (1069); Unstable (1667)

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

Event Date 06/03/2014

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's housing was unstable and that one of the screws holding the two parts of the housing together was broken.The customer also reported that it was possible that the hand pump was dropped, although it is unk how the damage occurred.The reported issue 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's housing was unstable and that one of the screws holding the two parts of the housing together was broken.The customer also reported that it was possible that the hand pump was dropped, although it is unknown how the damage occurred.The hand pump was returned to syncardia for evaluation.Visual inspection of the exterior of the hand pump revealed minor exterior scratches on the housing, and a rattling noise was heard emanating from inside of the unit while turning over the unit during inspection.Inspection of the interior of the hand pump revealed damaged pem nut standoffs, and loose piston assembly mounting bracket screws.The root cause for the customer reported issue is known to be the result of an impact shock.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; ce 2189; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3982792
• MDR Text Key: 4748744
• Report Number: 3003761017-2014-00087
• 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,User Facility,foreign,health profe
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Catalogue Number: 397004-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• 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