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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 142560488
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2023
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.
 
Event Description
The event involved a primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch.The reporter stated, at 18:00, after the chemotherapy drug (paclitaxel) was finished, it was switched to carboplatin, and after about 5 minutes, the patient felt their clothes was slightly wet.The patient immediately informed the nurse, who went to check on the patient.A white hole on the side of the carboplatin set filter was found, with drizzle-like spotty leakage (very slow).The pumping of the chemotherapy drugs was stopped immediately, and it was found that about 10cc had entered into the drug end (the front end of the set was still saline).The doctor on duty was notified.After checking, the patient had no physical abnormalities, a new abbott pump set was replaced, and infusion continued until the end of chemotherapy.There was patient involvement but no patient/healthcare provider harm.
 
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Brand Name
PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS 
Manufacturer Contact
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18053758
MDR Text Key327139131
Report Number9615050-2023-00595
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10887787005230
UDI-Public(01)10887787005230(17)251201(10)11352737
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number142560488
Device Lot Number11352737
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CARBOPLATIN, MFR UNK; PACLITAXEL, MFR UNK; PUMP SET, ABBOTT MFR; SALINE, MFR UNK
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