ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 140019291 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.
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Event Description
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The customer reported a general complaint stating, "for 8-10 months the oncology hospital has noticed an increase in cases of hypersensitive reactions after administration of chemotherapy, mainly oxaliplatin and a little carboplatin.The majority of these reactions are low grade.¿ the customer reported, "some patients involved in the events had their infusion rate reduced with premedication polaramine, hydrocortisone, hemisuccinate, and others had the protocol changed." there was patient involvement, however, there no delay in therapy and there was a need for medical intervention.The tubing used was not changed, the medication was changed in some patients' cases.
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Manufacturer Narrative
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H10: no product samples, videos, or images were returned for evaluation.The lot history was reviewed and no nonconformities were found which would have contributed to the reported complaint.The problem cannot be confirmed from the information provided with this complaint.
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Event Description
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Additional information received from the customer.The customer stated " for some patients, the therapy with platinum salts was completely stopped and other therapies continued.For some, the infusion rate was slowed down or suspended, then resumed with prescription of a higher dosage of anithistamine, corticosteroid, paracetamol and these patients continue with the same molecule the following therapies.No physical defect on the tubing¿.
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