HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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Model Number 06002-110-NA |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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On (b)(6) 2019 haemonetics received a reported complaint for a pcs2 machine which was observed to have a burning smell during the power on self test.Alpha source reported that the on-site technician replaced the fuses in the unit, when they powered on the device they observed a burning smell and removed the device from service.Haemonetics has sent a replacement a replacement device to alpha source as resolution.There was no report of injury as a result of the burning smell observed with no report of electrical arcing or fire, a small amount of visible smoke was reported.The failure of this component will prevent the device from passing the power on self test, which eliminates the risk of injury to a donor.There were no injuries reported as a result of this incident, however haemonetics has previously submitted reports of thermal decomposition observed within a device, as a result this incident is deemed reportable.
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Event Description
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On (b)(6) 2019 haemonetics received a reported complaint for a pcs2 machine which was observed to have a burning smell during the power on self test.Alpha source reported that the on-site technician replaced the fuses in the unit, when they powered on the device they observed a burning smell and removed the device from service.Haemonetics has sent a replacement a replacement device to alpha source as resolution.There was no report of injury as a result of the burning smell observed with no report of electrical arcing or fire, a small amount of visible smoke was reported.The failure of this component will prevent the device from passing the power on self test, which eliminates the risk of injury to a donor.
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