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Model Number N/A |
Device Problem
Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The getinge service territory manager (stm) that encountered the issue replaced the tubing assembly: "tubing, blood detect, iabp".The stm then completed a full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.The full name of the event site was shortened due to field character limit; the full name is: (b)(6).The initial reporter named is a getinge employee whose contact details are: (b)(6) which differs from that of the event site.
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Event Description
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It was reported getinge service territory manager (stm) during scheduled service for an unrelated repair.The stm discovered that some of the tubing was showing discoloration and appeared to be cracking in the cs300 intra-aortic balloon pump (iabp).The customer was not aware of this.The issue was not noticed previously and the unit was working with out any report of leaks.Since the event was found during service, there was no patient involvement, and no adverse event reported.
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Event Description
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It was reported getinge service territory manager (stm) during scheduled service for an unrelated repair.The stm discovered that some of the tubing was showing discoloration and appeared to be cracking in the cs300 intra-aortic balloon pump (iabp).The customer was not aware of this.The issue was not noticed previously and the unit was working with out any report of leaks.Since the event was found during service, there was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10, h11.Corrected fields: g3.
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Search Alerts/Recalls
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