ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE® CLEAR, R; STOPCOCK, I.V. SET
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Model Number MC33892 |
Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2022 |
Event Type
malfunction
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Event Description
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The event involved a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer that delivered an inaccurate dose of saline.The patient medication was for 20ml of saline using the closed med set as a flush but received/infused 100ml from 04:00 to 22:00.The patient received an extra 80ml of normal saline over an 18-hour time.A pump was not used with the set.The patient¿s condition was stable and stayed the same throughout.There was patient involvement but no report of patient harm.
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Manufacturer Narrative
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The device was received for evaluation.The investigation has not been completed.Additional information: initial reporter phone (cell) (b)(6).
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Manufacturer Narrative
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Received one used mc33892 transfer set connected to a 100ml bag of 0.9% sodium chloride for investigation.There was no visible damage observed.The transfer set was removed from the 100ml bag of 0.9% sodium chloride and water was easily drawn from a reservoir into a syringe connected to the microclave on the check valve.The complaint states there was no pump used during infusion.When attempting to discharge the water in the syringe through the transfer set to the distal end of the line it was not possible.There was a line occlusion.The transfer set was methodically disassembled to determine the source of the occlusion.All bonds were open and un-occluded, however there was residual substance in the microbore line leading to the distal end of the set that was occluding flow.The complaint was regarding over delivery of medication.There are no controls or means within the transfer set that would result in an over delivery.The complaint was unable to be confirmed.The transfer set was found to have occluded flow that was consistent with an infusate setting up and hardening after use, but no manufacturing errors were discovered.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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