Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 397002-001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199)
Event Date 04/09/2018
Event Type  malfunction  
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The results of the investigation will be provided in a follow up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver was supporting a patient when the patient experienced a non-related thrombus on his tricuspid valve on (b)(6) 2018.The customer also reported that the patient was switched to the backup companion 2 driver without adverse impact.The customer also reported that the companion 2 driver was subsequently rechecked and passed the system check out procedure.On (b)(6) 2018 the customer requested the companion driver be returned due to dissatisfaction.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The driver in "as received" condition passed all required functional testing requirements.Additionally, an extended observation run test was performed with no anomalies.The driver performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended in the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver was supporting a patient when the patient experienced a non-related thrombus on his tricuspid valve on (b)(6) 2018.The customer also reported that the patient was switched to the backup companion 2 driver without adverse impact.The customer also reported that the companion 2 driver was subsequently rechecked and passed the system check out procedure.On (b)(6) 2018 the customer requested the companion driver be returned due to dissatisfaction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key7453199
MDR Text Key106388243
Report Number3003761017-2018-00128
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number397002-001
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
-
-