MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Catalog Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot number of the device was not provided; therefore, the expiration and manufacture dates are unknown.Approximate age of device is not known.The patient remains ongoing with lvad support.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was placed on an extracorporeal circulatory support device on an unspecified date for right ventricular support and was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient was weaned off the centrimag on (b)(6) 2017 and the right ventricular assist device was removed at bedside; however, the patient remained intubated due to failed continuous positive airway pressure (cpap) trials.The patient developed atrial fibrillation with rapid ventricular response and was started on amiodarone.All chest tubes were removed and the patient continued to be febrile and with leukocytosis.Infection diseases was consulted.It was reported that the patient¿s leukocytosis and febrile condition were likely secondary to healthcare-associated pneumonia (hcap); however infective postoperative hematoma could not be ruled out.A start date of (b)(6) 2017 and stop date of (b)(6) 2017 were provided.No additional information was provided.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; thoratec switzerland gmbh; technoparkstrasse 1; ch-8005 zurich SC ; SZ
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7095389
• MDR Text Key: 94123715
• Report Number: 2916596-2017-03073
• Device Sequence Number: 1
• Product Code: KFM
• 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,study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102953
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HM3 LVAS - S/N OF (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 161