TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 Problems
Fluid/Blood Leak (1250); Battery Problem (2885)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.During the laboratory evaluation, the bpm unit does not operate on it's 12 volt (v) standby battery after alternating current (a/c) power was removed.Per the product surveillance technician (pst), the 12v direct current (d/c) battery is defective, as the battery has shorted and is starting to leak fluid.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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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the battery was not working on the blood parameter monitor (bpm) unit.The unit works when plugged in.The device was not changed out, as they are still using the unit.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Search Alerts/Recalls
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