TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
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Model Number 16402 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/21/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.The field service representative (fsr) arrived and discovered a roller pump with note attached that read "broken tongue".The fsr replaced the roller pump and the unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the perfusionist (ccp) stated the pump tongue was broken.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was confirmed.This pump is among a group from the same customer that all have a broken tongue.The field service representative (fsr) informed the investigator these broken tongues are due to repeated stress applied from stiff occlusion.No other failures were found from inspection of the pump.Fsr initially decided to order tongues but replacement tongues are not available at this time.The fsr gave the customer a loaner pump to use while the pump was returned to the manufacturer for repair.The device was sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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