MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II LVAS

Model Number 104911

Device Problem Detachment Of Device Component (1104)

Patient Problems Hemolysis (1886); Hematuria (2558)

Event Date 09/03/2014

Event Type  Injury  

Event Description

The pt was implanted on a left ventricular assist device (lvad).It was reported that the pt was readmitted due to hemolysis.The outpatient labs noted an elevated ldh of 1500 on (b)(6) 2014.The heparin was administered iv and the inr was greater than 2, a hematuria present, no chf symptoms or power elevations.An echo, x-ray and a ct scan were performed and no conclusive cause for hemolysis was found.No alarms were reported for the event.The pt will continue on heparin therapy and be medically managed.Frequent outpatient ldh checks were recommended.

Manufacturer Narrative

The pt continues on lvad support with no further issue reported.No further info is available at this time.A supplemental report will be submitted when the mfr's investigation is completed.

• Brand Name: HEARTMATE II LVAS
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORP.; 6035 stoneridge dr.; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth ave; burlington, MA 01803 ; 7812720139
• MDR Report Key: 4142688
• MDR Text Key: 4911223
• Report Number: 2916596-2014-01763
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Device Lot Number: 107489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 28 MO
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 80