TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000
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Model Number 16402 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported complaint has been confirmed.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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Event Description
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The product surveillance technician (pst) reported that during routine testing of the device at the service center, the molded pump tongue was broken.There was no patient involvement.
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Search Alerts/Recalls
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