PERFUSION SYSTEMS AFFINITY CP PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number BBAP40 |
Device Problems
No Flow (2991); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic investigation: the returned device impeller was loose inside the device.Visual inspection showed evidence of clotting/fibrin on both the upper and lower pivot.Additional inspection showed evidence of damage to the upper pivot.The device was tested per specification.The device was run on a bio-console from 0-4000 rpm¿s, using fluid.A noise level greater than 75 db was recorded, specification is less than 68 db.When the device was operating at the higher rpm's the impeller appeared to be pushed so far into the upper bushing that it started to decouple and appeared to slow down.The customer declined producing the anticoagulation record and confirmed it would show that heparin was only given when the patient was cannulated.It is noted that if the upper pivot bearing is not fully submerged in fluid, for example in the presence of a blood clot, this will cause the upper pivot bearing to degrade.Saline or blood is required during use to cool the ceramic bearing inside the pump.The excessive noise is attributed to the failing pivot bearing.Trends for issues with this product are reviewed at quarterly quality meetings.This investigation was completed with the information that was provided.If additional information is received this investigation will be reopened if deemed necessary.No further actions to be taken at this time.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that the customer reported a covid patient was on ecmo for two weeks.Perfusion was called stat to the patient's bedside and discovered the icu nurse was hand-cranking the centrifugal pump from the bio-console, which had stopped flowing.The nurse reported that the console/drive was making a grinding noise before the flow stopped.The perfusionist turned the pump off and then on, and then reseated the pump on the drive motor.Flow was re-established, but the pump/motor was still making a grinding noise.The decision was made to change out the entire ecmo circuit.The circuit was drained, including the pump, and no thrombus was discovered.There was no adverse effect to the patient.Additional information received from the medtronic sales rep: the pump was used for the entire 2 weeks the patient was on ecmo.The customer declined producing the anticoagulation record and confirmed it would show that heparin was only given when the patient was cannulated.Then, they would keep the ptt at 45-60.The customer estimated the handcrank was in use for a few minutes only.
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