MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, PREPIERCED Y-SITE, SECURE L; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140009290

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Event Description

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¿.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, PREPIERCED Y-SITE, SECURE L
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 10637564
• MDR Text Key: 212510735
• Report Number: 9615050-2020-00228
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: (01)(17)220601(10)4099929
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 140009290
• Device Lot Number: 4099929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARBOPLATIN, MFR ACCORD; OXALIPLATIN, MFG ACCORD