ICU MEDICAL COSTA RICA LTD. ENGLISH FOR CANADA, PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWA; PUMP, INFUSION
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Catalog Number 300106513 |
Device Problems
Failure to Deliver (2338); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned for evaluation; however, testing has not yet been completed.
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Event Description
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It was reported that, on an unknown date, a plum 360 experienced an immediate uncontrolled shutdown during a patient infusion.There was no patient harm reported.
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Manufacturer Narrative
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Complaint "of immediate uncontrolled shutdown" was confirmed when trying to perform the cassette test and the device alarmed n56 (replace battery) however when the alternate current (a/c) was disconnected the device powered off, also found this alarm in the alarm history logs.The probable cause is the battery.The battery was replaced and the cassette test with ac power or direct current (dc) power only was performed.All relevant performance verification testing (pvt) passed with no alarm or error codes.
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Search Alerts/Recalls
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