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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM SET
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ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Fluid/Blood Leak (1250)
Patient Problem Chemical Exposure (2570)
Event Date 03/06/2023
Event Type  malfunction  
Event Description
It was reported that an unspecified plum set with leaked an unspecified chemo drug during the night shift, around 11:30 pm.The patient's family went to the nurse station and informed the nurses that the c/t line was dripping.The nurse observed that there were droplets appearing at the vent hole when visiting the patient's unit.There was patient involvement, however, no patient harm was reported.
 
Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
 
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Brand Name
UNSPECIFIED PLUM SET
Type of Device
UNSPECIFIED
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 Key16911155
MDR Text Key314997783
Report Number9615050-2023-00134
Device Sequence Number1
Product Code FPK
UDI-Device Identifier00(01)(17)(10)
UDI-Public(01)(17)(10)
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
UNKNOWN
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 04/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
UNSPECIFIED CHEMO DRUG, MFR UNK.
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