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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 Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2020
Event Type  malfunction  
Event Description
Patient reported that when she mixed her cassette this morning and went to prime the pump alarmed high pressure. The patient then switched to alternate pump and got the same error when priming. Patient then mixed another cassette and was able to prime and infuse. No pump issues. Patient did not have lot information for cassette. No other information available. Did the pt have a backup device they were able to switch to? not necessary. If yes, was the pt able to successfully continue their infusion? yes. Is the infusion life sustaining? yes. What is the outcome of the event? resolved. Did the reported product fault occur while in use with the pt? yes. Did the product issue cause or contribute to pt or clinical injury? unk. Is the actual device available for investigation? no. Did we (mfr) replace the device? no. 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 Key10338365
MDR Text Key201064625
Report NumberMW5095779
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 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
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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