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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2020
Event Type  malfunction  
Event Description
Spontaneous call from patient's wife. Pump giving "no disposable" alarm. Pump was operating without any problems the previous day. Patient switched to backup. Back up pump also alarmed with same warning. Advised that problem is likely with the cassette and not the pump. Advised wife to mix a new cassette. Patient did not experience any adverse events. Fault did occur while pump was in use. No clinical injury. Cassette is available for investigation. Wife does not have the lot/expiration number of the faulty cassette. The infusion is life sustaining. Event is resolved. 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. No other details available. Reported to (b)(6).
 
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Brand NameCASSETTE MEDI RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key10250660
MDR Text Key198393816
Report NumberMW5095451
Device Sequence Number1
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 07/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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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