ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.70 ML, EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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Model Number 12515-01 |
Device Problems
Disconnection (1171); Failure to Deliver (2338)
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Patient Problems
Cardiac Arrest (1762); Thrombosis/Thrombus (4440)
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Event Date 02/20/2023 |
Event Type
Death
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Event Description
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It was reported that a patient expired in the cath lab due to the microclave® clear tubing not being connected.The facility indicated that they use the product as their primary tubing for 12517-01, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave¿ clear, purple clamp, rotating luer.The reporter added that they are trying to educate staff and make them aware that this connection is hard to attach and will come apart if not placed properly.The patient was having a cardiac catheterization for an acute myocardial infarction.During the procedure, a heparin bolus was given.The cardiologist noted thrombi building up around the cardiac wires while performing the procedure.Activated clotting time (act) level returned as normal and should have read high after receiving the heparin.The intravenous (iv) site and connections were checked beneath the sterile drapes, and it was found that the iv tubing had become disconnected from the iv extension tubing.Due to the patient not receiving any anticoagulants, thrombi formed within the cardiac artery, which resulted in a cardiac arrest.Resuscitation efforts were not successful, and the patient died.Upon querying the staff who have used this product, we found that it easily becomes disconnected from the iv tubing.No additional information is available at this time.
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Manufacturer Narrative
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The device is available to be returned for evaluation.However, it has not yet been received.
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Manufacturer Narrative
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The complaint of disconnection cannot be confirmed.No photos, videos, or samples were returned for evaluation.Multiple attempts were made to receive the reported devices or related samples of the same lot.No additional samples or information were provided.The device history review (dhr) was reviewed and no non-conformities were found that would have led to the reported complaint.Without the return of the used sample/samples, a comprehensive failure investigation cannot be performed.Additional/updated information can be found in d9.
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