TERUMO CARDIOVASCULAR SYSTEM CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR APS-1
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Model Number 801041 |
Device Problems
Device Inoperable (1663); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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After use of the device for a cardiopulmonary bypass procedure, the user reported that the motor of the six inch roller pump did not work.The user believes the belt on the roller pump is bad as it came off near the end, as they were wrapping up the case.The patient was already off the bypass equipment and there were no reported adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was not confirmed.Per field service representative (fsr), when he went back to the facility the unit was already working fine with no functional issues.No actions were taken since unit operated to the manufacturer's specifications.Product was not returned to manufacturer for evaluation as no failure was detected.The user facility clinical engineer confirmed that this roller pump is working and has no functional issue.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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