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 FREEDOM 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 FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 595000-001
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Congestive Heart Failure (1783); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Hypervolemia (2664); Test Result (2695)
Event Date 03/02/2018
Event Type  Injury  
Manufacturer Narrative
The freedom driver 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 customer, a syncardia certified hospital, reported that on (b)(6) 2018, the patient was admitted to the hospital for acute, high-grade, subclinical hemolysis.Hospital personnel reported that his ldh peaked around 1700 u/l and his plasma free hemoglobin levels ranged from 20-60 mg/dl.The patient was asymptomatic upon admission but developed hemoglobinuria on (b)(6) 2018 which resolved on (b)(6) 2018.The acute hemolysis occurred in the presence of hypervolemia, hypertension and right heart failure exhibited by elevations in central venous pressure, jugular venous distention and peripheral edema.The patient also presented with renal dysfunction with a serum creatinine > 2.0 mg/dl.The patient was switched from his primary freedom driver to a companion 2 driver on (b)(6) 2018 in an attempt decrease the hemolysis by manipulating the pressures and beat rate.On (b)(6) 2018 the patient was switched to a different companion 2 driver to determine whether the second companion 2 driver would provide any improvement in hemolysis.The patient was transferred to his backup freedom driver on (b)(6) 2018 after his clinical condition improved.The acute hemolysis event resolved by (b)(6) 2018 with stable ldh levels in the 800 ui/l range and plasma free hemoglobin levels in the 5-6 mg/dl range.The patient was re-discharged supported by the freedom driver on (b)(6) 2018.The freedom driver supporting the patient at the time of readmission for acute hemolysis was used by the hospital for off-site training on march 13 and 14, 2018.The site reported that the freedom driver would be returned to syncardia at the completion of training for investigation because of the hemolysis event experienced by the patient.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The customer-reported patient increasing hemolysis caused by a possible device malfunction was unable to be confirmed.A device malfunction could not be reproduced during investigation testing using the patient simulator because the dmc tank contains water, not blood.The driver passed all functional testing and was subjected to an additional 48 hour observation run in an attempt to observe a possible malfunction or change in performance.The driver performed as intended, and there was 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 on (b)(6) 2018, the patient was admitted to the hospital for acute, high-grade, subclinical hemolysis.Hospital personnel reported that his ldh peaked around 1700 u/l and his plasma free hemoglobin levels ranged from 20-60 mg/dl.The patient was asymptomatic upon admission but developed hemoglobinuria on (b)(6) 2018 which resolved on (b)(6) 2018.The acute hemolysis occurred in the presence of hypervolemia, hypertension and right heart failure exhibited by elevations in central venous pressure, jugular venous distention and peripheral edema.The patient also presented with renal dysfunction with a serum creatinine > 2.0 mg/dl.The patient was switched from his primary freedom driver to a companion 2 driver on (b)(6) 2018 in an attempt decrease the hemolysis by manipulating the pressures and beat rate.On (b)(6) 2018 the patient was switched to a different companion 2 driver to determine whether the second companion 2 driver would provide any improvement in hemolysis.The patient was transferred to his backup freedom driver on (b)(6) 2018 after his clinical condition improved.The acute hemolysis event resolved by (b)(6) 2018 with stable ldh levels in the 800 ui/l range and plasma free hemoglobin levels in the 5-6 mg/dl range.The patient was re-discharged supported by the freedom driver on (b)(6) 2018.The freedom driver supporting the patient at the time of readmission for acute hemolysis was used by the hospital for off-site training on march 13 and 14, 2018.The site reported that the freedom driver would be returned to syncardia at the completion of training for investigation because of the hemolysis event experienced by the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key7404391
MDR Text Key104659087
Report Number3003761017-2018-00098
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
-
-