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Model Number SET, ADMIN, CADD, 94", SPIKE, 0.2 FLTR, COILED TUBE, FS, |
Device Problems
Obstruction of Flow (2423); Protective Measures Problem (3015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2019 |
Event Type
Injury
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Event Description
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Information received a smiths medical cadd administration set tubing would not prime and stopped around air filter.Pump alarm displayed downstream occlusion.Two sets tried and the third set worked.Patient was receiving home visit with administration of vancomycin intravenous.No patient adverse events, as this would be a delay in therapy.
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Manufacturer Narrative
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One endotracheal tube was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The cuff of the returned sample was inflated using a syringe and the product was submerged under water in order to detect any leakage; leak observed between valve and pilot balloon.The bell-out, fit inflation line and leak test operations were audited during 32 units, in order to verify that the operations were properly performed.No discrepancies were detected.The reported customer complaint has been confirmed, and the problem source determined to be either that solvent was missing between pilot balloon and valve, or a lack of detection by production personnel.
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Event Description
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Information was received that the tube was changed out as a result.This incident is now a serious injury as this constitutes medical intervention.
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Search Alerts/Recalls
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