ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Catalog Number 42800-28 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 03/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
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Event Description
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The event occurred in the intensive care unit (icu) and involved a transpac it monitoring kit, 84" safeset reservoir, 2 blood sampling port, 3ml flush device, macrodrip where the blue ¿fast flush¿ device has broken off the plunger located on the pull back mechanism.A back flow of blood was noted through the pull back, out the hole on top of it and puddled onto the patient's floor.It was reported there was no medication involved.This report reflects the first incident of two.
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Manufacturer Narrative
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H10 - no product sample(s) were returned and no photographs or videos were provided for investigation.Therefore, a comprehensive failure investigation was unable to be performed.However, a parallel investigation was conducted on similar complaints which indicate the plunger was detached from plunger tip with the plunger tip unable to be pulled back within the safeset reservoir.The detached plunger from plunger tip would lead to unable to draw blood.The probable cause of the detached plunger tip from the plunger is due to the clips not being fully inserted or engaged into the mating component during the manufacturing process.A device history review (dhr) for lot# 4140090 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Additional information can be found in section h6.
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Manufacturer Narrative
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Additional contact information provided on the ufmw: (b)(4).
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Event Description
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A user facility mandatory medwatch, #(b)(4), was received on may 19, 2020.
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Search Alerts/Recalls
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