ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 142540489 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
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Event Description
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It was reported that on an unknown date a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch sets are leaking in high frequency in the chemo suites during patient use.The medication involved was paclitaxel.There were two drops on the patient, drops were absorbed onto a blue pad, the patient's skin was cleansed, and instructions were provided for laundering clothing.The chemo drug came into contact with clothing.There was unprotected chemodrug exposure to the patient.The chemo drug spill was cleaned up per facility protocol.There were no holes, cuts, tears, or any defects noted.The affected sample was attached to a tubing set with a closed system transfer device - chemolock.It was also stated that the chemo was coming out of the two circles on the back of the filter case.There was patient involvement and no patient harm.
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Manufacturer Narrative
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An image of the inline filter of the primary plum set was provided by the customer.Received one (1) used list #142540489 primary plum set connected to a chemolock connector.There was no damage or anomalies noted on the set either set.The returned sample was leak-tested per product specifications.There were no leaks observed.The complaint of leakage cannot be confirmed on the returned used sample.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 1/29/2024.
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Search Alerts/Recalls
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