ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" EXT SET, 3 GANG 1O2 MANIFOLD W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET
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Model Number B55013 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 02/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned for evaluation, but is yet to be received.
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Event Description
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The event was noted on the nightshift and involved a 12¿ extension set, 3 gang 1o2® manifold w/baseplate, rotating luer where a small crack was noted in the manifold causing lifesaving medication to slowly leak, reporting the leakage was subtle so accumulation was not noted.Leaking was noted at the bridge and a wet spot on the linen was noted where the bridge sat.Vasopressors (epinephrine, norepinephrine), narcotics (fentanyl, dilaudid), iv sedation (propofol) or maintenance iv¿s (d5/.9 or ns) were infusing through the 3 ports.The set up was continuous iv tubing with a minibore extension set, connected to the bridge of the device, which was in use within hours.The event was discovered when the patient became more conscious, fighting the ventilator or a blood pressure drop was noted due to leakage of medications.The patient experienced a drop in blood pressure requiring an intervention of a continuous infusion with the provided drugs used during the event to increase the patient¿s blood pressure and improve patient condition to avoid extubation and make the agitated patient more settled as the patient became restless and tried to pull out their breathing tube.It was reported that the patient was stable before the event, became unstable and a continuous infusion with the provided drugs used during the event to improve the patient condition, and then stabilized.
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Manufacturer Narrative
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One used list# b55013, 12" ext set, 3 gang 1o2¿ manifold w/baseplate, rotating luer (lot# 5039847) and three microclave connectors (list # unknown, lot# unknown) were received and visually inspected.As received, drug residuals were present within the extension set.Axial cracks were identified on the proximal female luer of the b55013 set.No mating devices were returned connected to the proximal damaged luer.The three microclaves were manually disconnected from the three manifold ports and examined.Crazing was observed on the second most proximal female luer port.This type of cracking and crazing is consistent with environmental stress.No additional damage or anomalies were found on the returned samples.The reported complaint of a crack resulting in leakage can be confirmed.The probable cause of the cracks and crazing observed is due to environmental stress applied to the luers during use.A device history review of lot# 5039847 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.D9 - device was received on 3/22/2021.
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Event Description
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Information was received stating that the nurses at the facility only manually tighten the device and use chlorhexidine gluconate (chg) wipes to wipe the device.
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Search Alerts/Recalls
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