ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 53 CM (21") ADD-ON 150 ML BURETTE SET (CLAVE¿, SHUT-OFF), VENTED CAP; STOPCOCK, I.V. SET
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Catalog Number 011-C7014 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Event Description
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The event involved a 53 cm (21") add-on 150 ml burette set (clave¿, shut-off), vented cap where it was reported the blue disc did not occlude the line on pediatric patient in the operating theatre.This resulted in air going down the line past the burette chamber.When they tried to refill the burette, the blue disc floated to the top of the burette.There was patient involvement and no patient harm.This captures 2 of 3 occurrences.
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Manufacturer Narrative
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The device is available for evaluation, however has not been received.E1 initial reporter address: (b)(6).
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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.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Updated information in d9.
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Search Alerts/Recalls
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