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
Catalog Number 397002-001
Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)
Patient Problems Edema (1820); Patient Problem/Medical Problem (2688)
Event Date 04/06/2018
Event Type  Injury  
Manufacturer Narrative
The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited diastolic waveform delay with decreased cardiac output while supporting a patient.The customer also reported that the patient became edematous and volume overloaded primarily in her abdomen and lower extremities requiring extra dialysis.The customer also reported patient was subsequently switched to the backup companion 2 driver.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The electronic patient data were reviewed and confirmed the customer-reported issue.During investigation testing, the diastolic waveform delay and decreased cardiac outputs were reproduced and the root cause was determined to be a malfunction of the pilot valves.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4259 follow-up report 1.
 
Event Description
The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited diastolic waveform delay with decreased cardiac output while supporting a patient.The customer also reported that the patient became edematous and volume overloaded primarily in her abdomen and lower extremities requiring extra dialysis.The customer also reported patient was subsequently switched to the backup companion 2 driver.
 
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 Key7453212
MDR Text Key106247169
Report Number3003761017-2018-00125
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier0858000003107
UDI-Public(01)0858000003107
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 04/06/2018
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
-
-