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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRI PLUM 15 MICRON CL 0.2M PE 272CM SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL COSTA RICA LTD. LS PRI PLUM 15 MICRON CL 0.2M PE 272CM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 140099290
Device Problem Fluid Leak (1250)
Patient Problem Rash (2033)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
The device is available for investigation. It is yet to be received.
 
Event Description
The event occurred on an unknown date. The customer reported a leaking filter of a plum oncology set during chemotherapy infusion. The involved drugs include doxorubicin, gemcitabine, paclitaxel, and cyclophosphamide. There was patient involvement with a reported rash, but no medical intervention was reported. Additionally, there was a delay in critical therapy.
 
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Brand NameLS PRI PLUM 15 MICRON CL 0.2M PE 272CM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS
Manufacturer Contact
emily arnould, bsn, rn
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key8804682
MDR Text Key151597168
Report Number9615050-2019-00273
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2021
Device Catalogue Number140099290
Device Lot Number929095H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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