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Model Number 21-2131-25 |
Device Problem
Failure to Infuse (2340)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/17/2020 |
Event Type
malfunction
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Event Description
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Information was received indicating that a smiths medical administration set was implicated in the following issue.The customer was running a cadd-solis pump with a communication module 2131.The customer reported that the pump showed error "communication module intermittent connection".According to the pump log, the error occurred in separated occasions for 7 days.The event-log also showed the error message during a patient infusion.The event log showed that the pump failed on the (b)(6) 2020 twice separate times after running an infusion program at 8:20 a.M and 12:21 p.M.There was no patient harm however, the patient had no pain relief for a number of hours until the patient was seen the next day.
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Manufacturer Narrative
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Other, other text: one device was returned for evaluation.Visual inspection of the device found it to have a damaged air detector.Review of the event history log found a high pressure alarm displayed, confirming the reported customer complaint.The error was noted to a result o the communication module not sitting tightly.This problem source has been determined to be manufacturing.
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Search Alerts/Recalls
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