ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET
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Catalog Number MC33332 |
Device Problems
Device Contamination with Chemical or Other Material (2944); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2023 |
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.Section e: additional contacts: (b)(6).
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Event Description
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The reported complaint involved a 128" (325 cm) appx 9.3 ml, transfer set w/microclave® clear, dual check valve, smallbore bifuse ext set w/microclave® clear (green ring), 0.2 micron filter, rotating luer.The customer reported that per their troubleshooting, it was revealed that the iv tubing caused the syringe pump to ring as occluded and it was not due to the piv itself causing any high pressure.The green air filter 0.2 micron filter had white precipitate in it.The patient was on penicillin g with a normal saline med line only used for medicine administration, not continuous infusions.The impact of the incident is that a new bifuse was hung and the remainder of medicine was given via new line.There was no apparent harm that reached a person.This emdr reflects the first of two occurrences.
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Manufacturer Narrative
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One used sample list #mc33332 (connected into 0.9% nacl 250ml bag) was returned and tested for investigation.Although a slow flow was observed at the end of the device, the solution flowed as normal through the filter vent.The set was then cut in the bond areas looking for a partial occlusion and no anomalies were found.The tube was found within specifications and no additional damage or anomaly was observed.The customer's complaint was not confirmed or replicated, as there was nothing wrong with the device's performance upon evaluation.The slow flow at the end of the device was because the length of the tube and the small inner diameter.The device functioned as expected.The lot history was reviewed and no non-conformities were identified that may have contributed to the reported complaint.Updated information can be found in g1.
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