Anonymous
Guest
Anonymous
Guest
Getting back tp the Costa Rica Warning Letter, I find this problem in part 3B interesting:
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b) Exception Report Record, PR ID: 41660, detailed a complaint of over-delivery by a Plum XLD pump. Your firm determined that the supplier, Benchmark Electronics, had installed the incorrect Y2 crystal board component, which had a frequency rating of 12 MHz instead of 16 MHz. The Y2 crystal sends signals to drive motors on the pump. In the exception report, the pump was programmed to deliver 1497 ml at a rate of 62 ml/hr. The device infused the entire dose 4 hours and 30 minutes early due to the incorrect Y2 crystal.
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When a 16MHz clock source is replaced with a 12MHz. the delivery should be slower, not faster. The dose should have completed later not earlier. But regardless, the infusion rate is off by about 20%. I assume they were able to quarantine the entire lot, otherwise there should have been a recall.
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b) Exception Report Record, PR ID: 41660, detailed a complaint of over-delivery by a Plum XLD pump. Your firm determined that the supplier, Benchmark Electronics, had installed the incorrect Y2 crystal board component, which had a frequency rating of 12 MHz instead of 16 MHz. The Y2 crystal sends signals to drive motors on the pump. In the exception report, the pump was programmed to deliver 1497 ml at a rate of 62 ml/hr. The device infused the entire dose 4 hours and 30 minutes early due to the incorrect Y2 crystal.
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When a 16MHz clock source is replaced with a 12MHz. the delivery should be slower, not faster. The dose should have completed later not earlier. But regardless, the infusion rate is off by about 20%. I assume they were able to quarantine the entire lot, otherwise there should have been a recall.