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

Catalog Number 397004-001

Device Problems Difficult to Insert (1316); Mechanical Problem (1384)

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

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the driveline issue was observed when not supporting a patient.The companion drivelines will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The companion drivelines were not supporting a patient.The customer, a syncardia certified hospital, reported that during a training session, the companion drivelines were difficult to insert into several hand pumps.

Manufacturer Narrative

The hand pump and companion drivelines were not returned for evaluation; therefore, no investigation of the customer-reported issue of driveline insertion difficulty could be confirmed.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4282 follow-up report 1.

Manufacturer Narrative

The hand pump and companion drivelines were returned to syncardia for evaluation.Visual inspection revealed multiple areas of cosmetic damage to the body of the hand pump.The customer-reported issue was confirmed via the functional inspection when the hand pump was unable to connect to the returned drivelines or any other drivelines.The root cause was determined to be a bent cpc (colder products company) connector on the driveline connection of the hand pump and a bent cpc connector on the companion driveline's driveline connector.The cause of this damage cannot be conclusively determined, but is likely the result of a drop or other rough handling as evidenced by the noted cosmetic damage.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 4282 follow-up report 2.

• Brand Name: SYNCARDIA HAND PUMP
• Type of Device: HAND PUMP
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7503996
• MDR Text Key: 108367081
• Report Number: 3003761017-2018-00198
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397004-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1