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Model Number CBAP40 |
Device Problems
Pumping Problem (3016); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis:visual analysis: the device was retursee pned bloody with evidence of damage around the top pivot.The device was cleaned in a 10% bleach solution.Visual inspection shows the impeller is loose inside the housing.Performance analysis: the device was run on a bio console from 0-3500 rpm¿s, using di water in the circuit, a noise level of 80 db was recorded, specification is less than 68 db.Conclusion: reason for return was confirmed for noise.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 a patient was been transferred while been on an ap40 pump, flow was 5.1 lpm at 2500 rpm¿s.The patient was not on anticoagulants.The flow dropped to zero and a hand crank was used successfully to produce flow.The back up driver was moved into position and forward flow was resumed at 3200 rpm¿s.A low grinding noise was heard and the device was replaced.During the change out there was no flow for 30 seconds.The patient had been on the ap40 for 10 days before the issue arose.It was asked but is unknown if there were any adverse effects to the patient.
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Manufacturer Narrative
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Investigation conclusion: the pump was used off label in regards to the 6 hr use and the patient was not on an anticoagulants.No further action required.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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