ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER,; STOPCOCK, I.V. SET
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Catalog Number 011-H3362-10 |
Device Problems
Break (1069); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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Event Description
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The event involved a 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter, 10 units that was reported to exhibit breakage during the percussion of the two paths with the icu administration device by the infusion pump tubing at approximately 03h3min pm.The tip of the spike broke and remained in the icu medical device, forcing the nurses to bring the bags back to the pharmacy to have the icu device changed out under the hood (isolator where cytotoxic drugs are prepared).Several drugs were used with this product.Information pertaining to this event was communicated by a call of the nurses to the service in charge of changing the icu device.When the device broke, the icu device contained only nacl 0.9% or g5% as a solvent.A procedure of exchanging out lot numbers is ongoing.There was no patient involvement, no adverse events/human harm.However, there was a delay in therapy as it was not possible to administer the treatment to the patient at the time of the event.This captures the third of three events reported at different healthcare services.
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it has not yet been received.
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Manufacturer Narrative
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The customer provided the following for investigation: one used return unit of 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter, 10 units; lot #5499160.One used list #unknown, infusion set; lot #unknown.As received, there was an unknown piercing pin broken off inside the dry spike adapter.The piercing pin was stuck and could not be removed using normal handling.However, the broken off piercing pin would not flow down the line of the fluid path.The complaint of broken piecing pin inside adaptor was confirmed on the used returned unit.However, there is no indication that loose foreign material within the fluid path would result in release of foreign material into the body of a patient based on the results of the investigation.The dry spike adapter met product design specification and there were no damages or anomalies that would lead to the stuck piercing pin.The probable cause of the stuck unknown piercing pin is unknown.D9 - date returned to mfg: 10jan2022.
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