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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problems Infusion or Flow Problem (2964); Pumping Problem (3016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Spontaneous call from remodulin iv patient, stated she had to mix a new cassette due to the 'no disposable' cassette error on her pump.She was familiar with the technique to nudge the bladder away from the sensor, but it does not always work.When it fails to resolve the error she replaces the cassette.Patient stated her infusion was running with the replaced cassette at time of call.The reported product fault did occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The cassette is available to be returned for investigation.The event is resolved.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Return tracking information is not available.No additional information is available at this time.Lot number is unknown.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key15550324
MDR Text Key301352401
Report NumberMW5112447
Device Sequence Number1
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 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/05/2022
Patient Sequence Number1
Treatment
EXTENSION SET; PUMP
Patient SexFemale
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