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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4076288
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
Spontaneous call from pt, cadd legacy pumps 423485, 322758 both showing no disposable found. Author had pt disconnect the cassette and reconnect it to make sure the connection is not loose. Pt stated tubing might not have any medication in it, but cassette volume was 67ml out of 100ml to rule that out. Author asked patient to try a new tubing with fresh cassette. Patient was sleeping when this alarm went off. Current cassette lot number 4076288. Pt did a new cassette with no problem. Did the reported product fault occur while in use with the patient? yes. Did the product issue cause or contribute to patient or clinical injury? no. Is the actual device available for investigation? yes. Did we replace device? no. 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. Is the infusion life-sustaining? yes. What is the outcome of the event? resolved. Unk if cassette is available for return. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCASSETTE MEDI RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11618985
MDR Text Key244259187
Report NumberMW5100571
Device Sequence Number3
Product Code FPA
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 03/06/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received04/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4076288
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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