TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 500AVHCT |
Device Problem
Degraded (1153)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The reported complaint was confirmed.The product will be sent to service to be brought to manufacturer¿s 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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Event Description
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The product surveillance technician (pst) reported that during laboratory analysis of the device, the power cord was found to be damaged with conductive wires exposed.There was no patient involvement.
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Search Alerts/Recalls
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