ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF; INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES
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Catalog Number 011-46115-21 |
Device Problems
Disconnection (1171); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2022 |
Event Type
malfunction
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Event Description
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The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port.It was reported that the safeset became loose and disconnected between the reservoir and the line going to the patient (the diluent set was disconnected from the two way valve).It appeared that the adhesive hadn¿t stuck and adhesive was observed at the point of disconnection.The safeset was replaced with a new one that was not loose and did not appear that it would come apart in the same area.The number of hours the device was used was 0.1.No medication was being used with the product.There was no leakage.Although there was a delay in therapy, there was patient involvement and no human harm.This captures the first of two events reported.
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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.The customer identified 3 possible lot numbers (plots): 5201049 (expiry date 02/01/2024, mfr date 03/01/2021).5254594 (expiry date 04/01/2024, mfr date 05/01/2021).5487785 (expiry date 07/01/2024, mfr date 12/01/2020).
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Manufacturer Narrative
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The complaint of separation can be confirmed on the returned used list #011-46115-21, transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port; lot #unknown.As received, the stopcock was separated from the base of the barrel reservoir.The area of the separation was examined.There was adhesive observed on the base of the barrel reservoir.However, the observed adhesive was tacky.The probable cause of the separation observed is due to uv adhesive not being fully cured during the manual assembly process during manufacturing.D9 - date returned to mfg: 7/7/2022.Additional entries can be found in a5, a6 and h6 (component code).
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