The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
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The event involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, 0.2 micron filter, clave y-site, polyethylene lined tubing, secure lock, 272 cm where leaking was reported.It was stated there was leaking from the corner of the filter, quite significantly at times.Someone became aware of the issue when leaking was noted from filter during delivery of fluid and medications.The medication used with the product was immunotherapy.The product was not reprocessed or re-sterilized prior to use.It was during use on a patient that the event occurred, and the product was in use for minutes.There were no holes, cuts, tears, or defects noted that can be seen by the naked eye.There was drug exposure to the patient, the spill was contained with personal protective equipment (ppe).There was no patient/ healthcare provider's impact.The chemo spill cleaned up per facility protocol, and spill kit used.The other product involved at the time of event was icu medical¿s plum set with list number 011-cl3020.There was patient involvement, with delay in therapy, but no one was harmed as a result of the reported event.This captures the second of two occurrences.
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