B. BRAUN MEDICAL, INC. B BRAUN INFUSOMAT SPACE PUMP IV SET; SET, ADMINISTRATION, INTRAVASCULAR
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Device Problems
Defective Device (2588); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2022 |
Event Type
malfunction
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Event Description
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Over the last few days, a cath lab nurse reported going through at least 10 bbraun infusomat spacepump iv sets as it caused tons of bubbles and air-in-line alarms in the bbraun pumps.Due to this observation and they decided to proceed with a different lot number which caused no further issues down the road.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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