TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 CARDIOPLEGIA MONITOR; COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR
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Model Number 16414 |
Device Problem
No Device Output (1435)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/26/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.
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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 temperature readings for a and b on the cardioplegia (cpg) monitor were blank.The device was not changed out, as they finished the case without the temperature readings.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 field service representative (fsr) tested all cardioplegia (cpg) monitor functions and could not duplicate the reported issue.The fsr removed the suspect monitor and installed a loaner cpg monitor and tested all functions.The unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.During the laboratory evaluation, the product surveillance technician (pst) confirmed the complaint.The pst connected the cpg monitor to a power supply and when powered on, the cpg temperature displays were blank, normally dashes are illuminated.The pst removed the temperature/pressure board out of a lab-tested cpg monitor and when installed into the returned monitor, the temperature displays illuminated as designed; dashes and temperatures (with a temperature probe inserted) were displayed.When the pst placed the suspect temperature/pressure board from the returned cardioplegia monitor into a lab-tested cardioplegia monitor and when powered on, no dashes or temperature displays illuminated confirming the complaint.The product will be 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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