ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT; CUSTOM KIT FOR SWITZERLAND
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Model Number 011-0J736-01 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned.It has not been received.The lot number of the device that was in use is unknown.The customer contact identified four possible lot numbers (plots).The possible lot numbers are 3424632, 3076351, 3360746, and 3300368.Expiration dates for the possible lot numbers are: 3424632 - 3/2020, 3076351 - 6/2018, 3360746 - 11/2019, and 3300368 - 7/2019.Device manufacture date for the possible lot numbers are: 3424632 - 4/2017, 3076351 - 6/2015, 3360746 - 11/2016, and 3300368 - 8/2016.
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Event Description
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The customer reported that a transpac iv set disconnected at the junction point with the luer connector.The customer reported this lead to blood loss for the patient that had no repercussion on the patient's health condition.There was no reported delay of critical therapy and no medical interventions required.
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Manufacturer Narrative
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No product was received for investigation, but two photos showed arterial tubing separation.The cause of the separation cannot be determined without the product being returned for investigation.A dhr (device history record) review was completed on the following suspect lot numbers: 3424632, 3076351, 3360746, 3300368.No non-conformities were noted for the assembly and relevant subassemblies.This complaint is related to pr (b)(4), which had two (2) samples returned for investigation and that complaint was confirmed due to insufficient solvent for one of the samples.Two other prs are also related (b)(4), which had no product returned.The reported complaint of tubing separation was confirmed.Without the actual sample returned, the cause of the separation cannot be determined.Subsequent to the submission of the initial medwatch report, the device did not return for evaluation.
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Search Alerts/Recalls
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