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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
Lot Number UNKNOWN
Device Problems Defective Component (2292); Fungus in Device Environment (2316); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Per patient's spontaneous call to technician: ¿ pt stated every time she gets cassette she gets some that are damaged and appear to have something like trash or mold in the cassettes and she is not comfortable using them, said she tells pharmacist and every other month she gets between 5 to 15 damaged/defective cassettes.She said she spoke with the manufacturer product complaint person (b)(4) and they sent her a box to return them and never got back to her so she is not sure what else to do besides order extra.¿ patient has had multiple problems with cassettes since (b)(6) 2019 (previously reported).Special forms previously submitted to smiths medical.Pt has problems with multiple lot numbers.Escalated to supervisors per technician.Request also sent to md/practice liaison to advise on how to proceed.No other information /dates/details were provided at this time.Reported to (b)(6) by: patient/caregiver.Dates of use: (b)(6) 2019 to current.
 
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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 Key10301840
MDR Text Key201844908
Report NumberMW5095633
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 07/16/2020
15 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10   11   12   13   14   15  
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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