An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).An abbott field service representative (fsr) found a burned r100 component on the main electronics board, part number (b)(4).The board was replaced to resolve the issue.The accelerator aps operations manual and the centrifuge operations manual were reviewed.Troubleshooting and safety information is provided.Customer complaint data was reviewed and an increase in failures for the main electronics board, part (b)(4) triggered an alert which suggests an adverse trend.The failure prevents the centrifuge from performing as expected.Based on this information a product deficiency was identified and further investigation is being performed.A follow up report will be submitted at the completion of the investigation.Investigation ongoing.
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A product deficiency was identified due to an increase in complaints for failures of the r100 component of the main electronics board (parts 8-35003665-01 and 8-206623-01).The supplier, (b)(4), determined that the issue is from the r100 component of the hettich centrifuge board which was too small to withstand a current spike.Hettich released an enhanced main board revision 06 with a different r100 resistor.It is considered acceptable to continue using the automation system because the issue does not impact operator nor patient safety.The accelerator aps operations manual and the centrifuge operations manual were reviewed and show that troubleshooting and safety information is provided.There have been no reported injuries for this issue.If the electrical components of the main electronics board fail, it will shut down the centrifuge module.If the centrifuge shuts down, the operator will receive an error message.The frequency of this hazard was assessed and it was determined that though there was a trend in complaints, the overall frequency of low had not changed from the predicted frequency as outlined in the risk management file.
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