Catalog Number 0684-00-0575 |
Device Problems
Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591); Gas/Air Leak (2946); Improper Flow or Infusion (2954); Torn Material (3024)
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Patient Problem
Death (1802)
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Event Date 07/25/2016 |
Event Type
Death
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Manufacturer Narrative
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The device has not been returned to the manufacturer and we're unable to complete an evaluation on the affected product.When its' provided we will send a supplemental report with additional findings.We continue in our efforts to follow up with the customer for its' return.(b)(4).
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Event Description
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The patient had a 50cc iab catheter inserted; at approximately 0553 hours the balloon began to alarm ¿gas loss in circuit¿.At this time all connections were checked and no blood was observed.The balloon began to auto fill, restarted and quickly alarmed again, upon inspection the catheter and helium lines had blood in them.The catheter was removed to prohibit the flow of blood and a new balloon was used.When the replacement balloon was inserted it was found to be torn, a third balloon was subsequently used and therapy restarted.At about 12:35 it began to alarm, ¿gas loss in circuit¿ and blood was also found in both the helium and catheter lines.The therapist clamped both lines and the balloon was removed by the physician.At this time it was decided to not replace the third balloon as it was going to be removed that day anyway.Roughly an hour later the patient expired.
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Manufacturer Narrative
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Date rec'd by mfr was not entered in the initial mdr.Date: 07/25/2016.
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Event Description
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The patient had a 50cc iab catheter inserted; at approximately 0553 hours the balloon began to alarm ¿gas loss in circuit¿.At this time all connections were checked and no blood was observed.The balloon began to auto fill, restarted and quickly alarmed again, upon inspection the catheter and helium lines had blood in them.The catheter was removed to prohibit the flow of blood and a new balloon was used.When the replacement balloon was inserted it was found to be torn, a third balloon was subsequently used and therapy restarted.At about 12:35 it began to alarm, ¿gas loss in circuit¿ and blood was also found in both the helium and catheter lines.The therapist clamped both lines and the balloon was removed by the physician.At this time it was decided to not replace the third balloon as it was going to be removed that day anyway.Roughly an hour later the patient expired.
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Search Alerts/Recalls
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