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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR LEGACY; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR LEGACY; SET, I.V. FLUID TRANSFER Back to Search Results
Lot Number 4235242
Device Problem Nonstandard Device (1420)
Patient Problems Arrhythmia (1721); Dizziness (2194)
Event Type  Injury  
Event Description
Spoke with the pt who has all cassettes defected.Lot# 4315908, 4321040, 4235242 and 4226242.Patient was dealing with pump alarming for the last few months.Patient reported yesterday that she felt a race heart beat and dizziness.Advised her to seek an immediate medical attention.No further info.Iv remodulin pt.No add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? yes; did the pt have add'l cassettes they were able to switch to? no; if no, what was the pt instructed to do in able to continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
CASSETTE MEDI RESERVOIR LEGACY
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key16026001
MDR Text Key306070587
Report NumberMW5113889
Device Sequence Number3
Product Code LHI
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/15/2022
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received12/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Lot Number4235242
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient SexFemale
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