MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Bacterial Infection (1735)

Event Date 09/05/2017

Event Type  Injury  

Event Description

Pt has heartmate ii left ventricular assist device.Pt was seen in (b)(6) clinic (b)(6) to assess drainage at driveline exit site that was reported by patient on (b)(6) 2017.Pt had drainage - culture and labs obtained at that time, empiric antibiotic started.Culture result received (b)(6) showing achromobacter bacterial infection.Pt was admitted to the hospital (b)(6) 2017 for further evaluation and treatment.

• Brand Name: HEARTMATE II
• Type of Device: HEARTMATE II
• Manufacturer (Section D): THORATEC CORPORATION; pleasanton CA
• MDR Report Key: 6876808
• MDR Text Key: 86746184
• Report Number: 6876808
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2017
• Distributor Facility Aware Date: 09/01/2017
• Device Age: 38 MO
• Event Location: Home
• Date Report to Manufacturer: 09/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 95