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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 Alarm System (1012)
Patient Problems Fatigue (1849); Itching Sensation (1943)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
Spontaneous call from the patient stating that the backup pump had failed. Patient was sent to the hospital. While at the hospital, the failed pump was restarted by (b)(6). There was minimal interruption to therapy. Pump did not need to be replaced. No further intervention was needed. No further information is known. Serial number of pump: (b)(4). The fault did occur while in use. The patient did not have any ill effects or clinical injury. No intervention was needed or provided to/for the patient. The device will be available to investigate once (b)(6) gets it back from the patient. Did we [mfr] replace device? yes; did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes. 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 Key11307668
MDR Text Key231405229
Report NumberMW5099330
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 02/08/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
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? No

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