Model Number 500AVHCT |
Device Problem
Improper Device Output (2953)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per subsidiary, during set-up the monitor was adjusted to match the sensors value.The blood gas from the lab analyzer showed 4.0 but when it was entered into the blood parameter monitoring (bpm) the value decreased to around 1.0 to 2.0 within a few minutes.The bpm was calibrated 10 times and the shunt sensor was replaced but the issue remained.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, abnormal potassium (k+) values were displayed.As a result, an alternate device was employed.The surgical procedure was completed successfully with one cubic centimeter (cc) of blood loss.There was no delay, nor adverse consequences to the patient.
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Manufacturer Narrative
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Evaluation is in progress, but not yet concluded.(b)(4).
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Event Description
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Per clinical review: the blood parameter monitor (bpm) was used on an extracorporeal membrane oxygenation (ecmo) patient and the information we currently have is that the potassium (k+) code was placed in the monitor, and the user states that after a store recall incident the value of 4.0 meq/l drifted down to 1.0 and 2.0 meq/l.Recalibration was done this was for in-vivo approximately 10 times, and each time the entered value decreased.Ecmo is off label use for the bpm, and it is not known how long the bpm and the shunt sensor was in use for this patient.It is also not known if the second shunt sensor placed in the ecmo circuit was gas calibrated and if the k+ value was placed in the monitor for the second shunt sensor.It is noted after the second sensor showed the same result, the team exchanged the bpm, without seeing a resolve in the k+ value.The occurrence did not delay the ecmo run/procedure.There was 1.2cc of blood loss associated with a change out in the shunt sensor.There was no harm associated with this event.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed the blood parameter monitor (bpm) to pass all startup self-diagnostics with no errors and was gas calibrated successfully.The pst placed the monitor in operate mode for 16 hours.After six hours the potassium (k+) value remained as set via in vivo.After 16 hours the k+ reading had increased by did not drop.
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Manufacturer Narrative
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The reported complaint was not confirmed.During blood loop analysis, the unit did not exhibit the reported inaccuracies.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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