Model Number 10014914 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
Underdose (2542)
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Event Date 02/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: (2) used ganged stopcocks (unspecified manufacturer) and (1) used non-bd set; 10ml covidien syringe; td (b)(6) 2020.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, no patient information provided.
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Event Description
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It was reported that the there was a maxzero crack and leak.The event occurred in the cvicu.Per the reporter, "blood back up in white cvl lumen- into train." a crack was found which resulted in a precedex leak.The patient did not receive full dose of precedex and milrinone as a result.
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Manufacturer Narrative
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Continued from d.11:(2) used ganged stopcocks (unspecified manufacturer) ;used non-bd set; td (b)(6) 2020.Additional info: d.11.
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Event Description
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It was reported that the there was a maxzero crack and leak.The event occurred in the cvicu.Per the reporter, "blood back up in white cvl lumen- into train." a crack was found which resulted in a precedex leak.The patient did not receive full dose of precedex and milrinone as a result.
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Manufacturer Narrative
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The customer¿s report that the there was a maxzero crack and leaked causing blood to back up was confirmed.Visual inspection observed a lateral crack in the female luer wall of the set located at the top end of the female luer opposite of the luer gate.Residual blood was also observed within the 2 ganged stopcocks.Functional testing showed small droplets were leaking at the connection between model mz1000-07 and model 10014914.The root cause of the female luer crack was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.A device history record for model mz1000-07 with lot number 19107081 was performed.The search showed that a total of 76,803 units were built in 1 lot on 26oct2019.The search showed that there were no quality notifications for the failure mode reported by the customer.A device history record for model 10014914 with lot number 19087377 was performed.The search showed that a total of 12,003 units were built in 1 lot on (b)(6) 2019.The search showed that there were no quality notifications for the failure mode reported by the customer.
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Event Description
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It was reported that the there was a maxzero crack and leak.The event occurred in the cvicu.Per the reporter; "blood back up in white cvl lumen- into train".A crack was found which resulted in a precedex leak.The patient did not receive the full dose of precedex and milrinone as a result.Although requested, there has been no further impact to patient response or additional event information made available to date.
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Search Alerts/Recalls
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