ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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Model Number MC9079 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No sample was returned.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review for lot# 4915987, relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Additional reporter information: (b)(6): due to system limitations, date returned to mfg is populated with 10/26/2020, however no device was returned.
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Event Description
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User facility medwatch report was received and stated the following: air bubbles present between filter and patient.I was changing hal (hyperalimentation) and il (intravenous) lines infusing through a picc line.I had primed the tubing, checked for and dispelled air bubbles in the line.Once the line was attached to the patient, air bubbles developed between the filter and the patient.The infusion was immediately stopped, a new filter was primed and reattached to the patient.Again air bubbles appeared in the same area of the line.Another rn then primed a whole new line, no further air bubbles noted.The remaining stock of filters of that lot number were pulled for testing.The original intended procedure was iv infusion.The problem that the user have was device failure (e.G.Broke, couldn¿t get it to work or stopped working).There was patient involvement but no harm reported.This report is for the second of two devices.
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