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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE; SET, I.V. FLUID TRANSFER Back to Search Results
Lot Number 4163625
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Spontaneous call from patient reporting 2 cassettes last night gave her the error message of no disposable.This happened on both pumps.She mixed a new cassette and pump has been running fine since 7:30 pm last night.Patient has order arriving tomorrow, does not need any additional supplies at this time.Did the reported product fault occur while in use with a patient? yes did the product issue cause or contribute to patient or clinical injury? no.Is the cassette available to be returned for investigation? yes.Did we [mfr] replace the cassette? yes.Did the patient have additional cassettes they were able to switch to? yes, if yes was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? what is the outcome of the event? resolved? ongoing? resolved.Has this incident happened within the past 6 months? yes.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
CASSETTE
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key13290271
MDR Text Key284171364
Report NumberMW5106781
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 12/02/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number4163625
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CADD PUMP
Patient SexFemale
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