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

Catalog Number 102953

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Thrombus (2101)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

The serial number of the device is not known.Due to the urgency of the operative case, the device packaging and serial number information was disposed of in the operating room.The approximate age of device: 12 days (calculated from date of implant to date removed.) the device manufacturer date is not known.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device.It was reported that the patient was returned to the operating room (or) during the first postoperative night on (b)(6) 2016 for "clotted off lines." it was reported that the bedside nurse clamped the outlet and inlet blood tubing due to visualized clot with "layering/separating of blood" in the blood tubing.Flow of 0.0lpm was displayed on the device console.It was reported that the low flow alarm limit had not been set by hospital staff, and that the console was not alarming.The patient tolerated the disruption in support for a period of time; however, eventually became hemodynamically unstable.The patient was started on inotropic and vasoactive support due to mean arterial pressure between 20-30mmhg, and was returned to the operating room after exchanging the device and removing clot from the blood tubing, the patient stabilized.It was reported that there was not an issue with the extracorporeal circulatory support device or the primary console.The blood tubing had been caught under the patient's leg, and the tubing then clotted.The patient was brought back to the o.R.On (b)(6) 2016 to evacuate chest hematoma, and the patient was then weaned off of device support at that time.

Manufacturer Narrative

The reported event of thrombus within the centrimag circuit could not be determined during the investigation as the pump was not returned for evaluation.The lot number of the centrimag blood pump was not provided; therefore, device history record review could not be completed.The centrimag blood pump instructions for use lists thromboembolic phenomena as possible side effects that may be associated with the use of the centrimag blood pump and warns the user to monitor the circuit carefully for any signs of occlusion.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6065009
• MDR Text Key: 58699525
• Report Number: 2916596-2016-02100
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 07/07/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 129