Model Number N/A |
Device Problems
Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 08/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge field service engineer (fse) was dispatched to investigate the report of a blood back event.Upon evaluation of the iabp, the fse observed blood in the unit and no failure was identified.The fse replaced the following components due to blood contamination: reservoir assembly, purge valve assembly, condensation removal module (crm) english, safety disk assembly english and iabp blood detect tubing.Full functional and safety tests were performed and the iabp unit passed all functional and safety checks per factory specifications.The iabp was returned to the customer and cleared for clinical use.The full name of the initial reporter is (b)(6).
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Event Description
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It was reported by the nurse in the coronary icu that earlier in the day the patient had a cardiac arrest.The staff noted that the intra-aortic balloon (iab) had blood in the helium tubing that may have entered the intra-aortic balloon pump (iabp).The staff removed the iab and pulled the iabp from service.The pump was sent to the biomed without knowledge as to whether service is needed.There was no reported malfunction of the iabp.The iab used during this event has been reported under mfg report number (b)(4).
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.
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Event Description
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It was reported by the nurse in the coronary icu that earlier in the day the patient had a cardiac arrest.The staff noted that the intra-aortic balloon (iab) had blood in the helium tubing that may have entered the intra-aortic balloon pump (iabp).The staff removed the iab and pulled the iabp from service.The pump was sent to the biomed without knowledge as to whether service is needed.There was no reported malfunction of the iabp.The iab used during this event has been reported under mfg report number 2248146-2019-00722238631.
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Search Alerts/Recalls
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