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 816571 |
Device Problem
Fracture (1260)
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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 was confirmed.The srt replaced the tube clamp knob.The unit operated to the manufacturer¿s specifications.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 service repair technician (srt) reported that during routine testing of the device at the service center, the tube clamp knob was damaged.There was no patient involvement.
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Search Alerts/Recalls
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