Model Number 195240 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2020 |
Event Type
malfunction
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads would not adhere to the reservoir.As a result, level sensor pads from another box were used.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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Updated blocks: d9 and h3 h3: 81 - evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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Per the perfusionist, the sensors were mounted on a flat surface on the bottom right of the reservoir and were connected within a minute of placement of the holder.During laboratory analysis, the product surveillance technician (pst) adhered 12 mounting pads to a lab use only (luo) cardiotomy / venous reservoir.The pads adhered very well and were removed with a flat head screwdriver and with significant effort.The pst did not observe any issues with the mounting pads.
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Manufacturer Narrative
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Updated block: h6.The reported complaint was confirmed.It was determined that the user was attaching the sensor to the mounting pad within a minute of applying the pad to the reservoir.The user was reeducated on the application of the mounting pads and advised to wait the full five minutes to allow full adhesion.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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