SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 60-02-60 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/20/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the panel of sorin centrifugal pump 5 (cp5) displayed dashed lines during priming, indicating no fluid present, even though there was fluid present.The unit was restarted to correct the issue.There was no patient involvement.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that the panel of sorin centrifugal pump 5 (cp5) displayed dashed lines during priming, indicating no fluid present, even though there was fluid present.The unit was restarted to correct the issue.There was no patient involvement.
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