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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 Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2020
Event Type  malfunction  
Event Description
Patient reports a "no disposable" error on his pump, switched to backup pump and got the same alarm.The chance of both pumps malfunctioning at the same time small so this may be a cassette issue.Suggested he try mixing a new cassette.Patient attempted to stop and re-align cassette again which resolved alarm.Patient was able to resume infusion at time of call.Pump serials (b)(4) and (b)(4).Patient did not have cassette product information.No other information.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 actual device is available to be returned for investigation? yes; did we replace device? no, not needed; did the patient have a backup device they were able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes.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.
MDR Report Key10465730
MDR Text Key205093880
Report NumberMW5096324
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 08/24/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/27/2020
Patient Sequence Number1
Patient Age61 YR
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