ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number MC33150 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review could not be completed due to the unknown lot number.
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Event Description
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The incident involved a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer.It was reported that a patient had an allergy to silicone on an unknown date.The patient used a steroid cream for a raised red rash where the tubing was against the skin.There was patient involvement and patient allergy, but no patient harm was reported.
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Manufacturer Narrative
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The device has been discarded and is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.D9 selection.
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Event Description
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The customer provided additional information regarding the incident on 15-feb-2023.The patient was self-administering and removing her own peripheral intravenous (piv) lines in the home.Additionally, it was stated that the device was an extension set and remains attached to the patient¿s piv catheter.The medications involved were intermittent infusions of dextrose 5% 1/4 normal saline and ondansetron.It was also stated that the tubing was replaced and therapy was resumed.The patient tried to create a barrier between the skin and the tubing with gauze; however, the patient continued to have issues.Eventually, the doctor's office requested they put a tegaderm dressing on the skin so the extension set wouldn¿t touch it.The patient was treated with a steroid injection and topical for raised red rash.
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Search Alerts/Recalls
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