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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CASSETTE; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC CADD CASSETTE; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
During remunity consult, patient reported that 2 of the cartridges out of her last shipment from (b)(6) 2022 only lasted 48 hours (normally would last 70 hours].The patient reports that her device beeped and notified her that her medication was depleted at 48 hours.This only occurred with 2 cassettes.This did not interrupt patient's therapy and patient did not experience any clinical injury.Patient reports that she has had issues with cassettes in the past.Cnss contact previously sq remunity patient is at maintenance dose of 54.64 ng/kg/min with pump rate of 22 ul/hr.Other occurrence dates not provided.No adverse events reported.Patient has nothing available to return at this time.Lot and expiration info are unknown.No additional information is known at this time.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 event is resolved.Describe in detail any, and all damage to the cassette: this incident has not happened within the past 6 months.Issues with cassettes has occurred in past 6 months.Not this specific issue.This patient has not reported a pump malfunction within the past 6 months.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
CADD CASSETTE
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
MDR Report Key15800457
MDR Text Key303930362
Report NumberMW5113279
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 11/10/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient SexFemale
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