MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT,; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140019291

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is 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.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT,
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10631483
• MDR Text Key: 212510297
• Report Number: 9615050-2020-00224
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100128
• UDI-Public: (01)10887709100128(17)220901(10)4186659
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 140019291
• Device Lot Number: 4186659
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1