ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM; STOPCOCK, I.V. SET
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Model Number MC330027 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available for evaluation.It has not been received.
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Event Description
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The event occurred on a unspecified date and involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock that the customer reported the patient's mom called the nurse into the room because the line broke and was leaking but the spiros and part of the trifurcation still was attached.The blood was flowing back and chemotherapy (cytarabine continuous 2ml/hr and maintenance intravenous fluids (mivf) running.Everything was put on hold and the clave was changed and all new tubing was made.The nurse practitioner was notified.There was a loss of chemotherapy less than 5% so no changes were made.There was patient involvement and no report of patient harm.
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Manufacturer Narrative
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One used partial 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, luer lock was received for evaluation on 5/12/22 and visually inspected.As received, the distal tubing and bonded male luer were missing from the assembly and not returned.Some solvent was present within the empty bond pocket of the trifuse connector.No other damage or anomalies were identified.The dimensions of the bond pocket were measured and found to meet design specifications.The reported complaint of a tubing separation and subsequent leakage can be confirmed.However, without the return of the separated tubing a probable cause cannot be determined.Lot history review could not be conducted because no lot number(s) was/were identified.
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Search Alerts/Recalls
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