TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
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Model Number 801041 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.The reported complaint occurred when the unit was being set-up for a safety inspection.
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Event Description
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It was reported that during use of the device for a non-clinical activity, the display flickered and was unreadable.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).During laboratory analysis, the product surveillance technician (pst) observed the display to flicker with missing graphics.The pst replaced the customer's graphics driver board with lab use only graphics driver board which restored functionality determining customer's graphics driver board was defective.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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