Concomitant medical products: primary console: serial number (b)(4), manufacture date: july, 2013; ship date: 10/03/2013.The motor is not a single use device.Approximate age of the device is 8 years, 1 month calculated from the ship date of the motor (10/31/2008).The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.
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The patient was placed on extracorporeal membrane oxygenation (ecmo) on (b)(6) 2016.On (b)(6) 2016, it was reported that the patient developed a clot in the pump.This equipment had been placed on the patient on (b)(6) 2016.It was reported that the motor became hot to touch, and that no alarm was elicited from the console.The pump was exchanged; however, the motor would not operate the pump.After the console and motor were exchanged to the backup, the system functioned as expected.It was reported that on (b)(6) 2016, the patient expired, likely from a clotting disorder.It was reported that the patient's condition had started to deteriorate prior to the event.No additional information was provided.
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