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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM 360 PUMP; PUMP, INFUSION
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ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM 360 PUMP; PUMP, INFUSION Back to Search Results
Catalog Number UNKNOWN
Device Problem Inaccurate Flow Rate (1249)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 02/01/2023
Event Type  malfunction  
Event Description
The event occurred on an unspecified date involving an unspecified plum 360 pump where it was reported that when the customer has an alarm for volume infused, the pump goes down to a rate of 1cc.If they do not remember to set up the vasoactive drip to post infusion rate before starting it, they have to turn it off and start all over again which takes up to 3 minutes to reprogram and has caused hypotensive events in their patients.There was patient involved and patient harm of hypotension.
 
Manufacturer Narrative
It is not known if the device is available for evaluation.Without the return of the device a probable cause could not be determined.
 
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Brand Name
UNSPECIFIED PLUM 360 PUMP
Type of Device
PUMP, INFUSION
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 Key16582891
MDR Text Key311678011
Report Number9615050-2023-00078
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNSPECIFIED VASOACTIVE DRIP, MFR UNK.
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