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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 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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ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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
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.
 
Manufacturer Narrative
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.
 
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¿.
 
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Brand Name
PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS 
MDR Report Key10635533
MDR Text Key210008821
Report Number9615050-2020-00226
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10887709100128
UDI-Public(01)10887709100128(17)230101(10)4495819
Combination Product (y/n)N
PMA/PMN Number
K141789
Number of Events Reported1
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 Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2023
Device Catalogue Number140019291
Device Lot Number4495819
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARBOPLATIN, ACCORD MFR; OXALIPLATIN, ACCORD MFR; CARBOPLATIN, ACCORD MFR; OXALIPLATIN, ACCORD MFR
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