DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-57 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/03/2021 |
Event Type
Death
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Manufacturer Narrative
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Testing of actual/suspected device : the distributor's getinge trained field service engineer (fse) was dispatched to investigate.The fse performed preventative maintenance (pm) and reviewed and cleaned the electrical and pneumatic systems.Additionally there was an internal and external cleaning of the iabp unit.All functional checks were reviewed for the auto-filling module, vacuum system, screen, buttons, module, battery, ventilator module, and correct acquisition and operation of the ecg signal was confirmed.The fse verified proper function of the alarms with images, codes and sound.The screen was observed to be in good condition and image projection and push buttons were in good working condition and functional.Functional and printing tests successfully passed.The iabp unit was cleaned and observed to be in good physical condition and operating under normal conditions.The fse proposed to carry out functional tests for two (2) days with a simulator and a factory balloon.A supplemental report will be submitted when additional information is provided.The first name of the initial reporter in has been abbreviated due to field character limit; the full name should read (b)(6).The full name of the event site in was shortened due to field character limit; the full name is hospital (b)(6).
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) generated an error code #7.The iabp unit was swapped out; however, the patient was reported to have died.The customer has not attributed the patient's death to the device.
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Manufacturer Narrative
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Additional information obtained from invima report (b)(4): (translation) the getinge distributor identified that the error was associated with accumulation of dust in the area of the internal fans, corrective is made and the equipment is left in simulator testing for 3 consecutive days and the error is not replicated.The iabp unit was then cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.Patient height: 170cm.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h10.Corrected field h6 (health effect - clinical code).It was later reported that the patient was diagnosed with sudden cardiac death.
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Manufacturer Narrative
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Updated fields: b4, g2, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).
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Event Description
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N/a.
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Search Alerts/Recalls
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