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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRIMARY PLUM SET 15 MCRN SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL COSTA RICA LTD. LS PRIMARY PLUM SET 15 MCRN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 140019290
Device Problem Fluid Leak (1250)
Patient Problems Rash (2033); No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
The device is expected to return for evaluation. It has not been received.
 
Event Description
The event occurred on an unspecified date and involved a plumset that was leaking during chemotherapy. No additional details were provided.
 
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Brand NameLS PRIMARY PLUM SET 15 MCRN
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 Key8786264
MDR Text Key150880798
Report Number9615050-2019-00252
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
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2021
Device Catalogue Number140019290
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 Received07/16/2019
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

Patient Treatment Data
Date Received: 07/12/2019 Patient Sequence Number: 1
Treatment
UNSPECIFIED CHEMOTHERAPY
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