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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2020
Event Type  malfunction  
Event Description
Per pt, one of her cassettes arrived damaged last fill. Lot number not known. No other info known. Prescriber has not been notified. Did the reported product fault occur while in use with the pt? no. Did the product issue cause or contribute to pt or clinical injury? no. Is the actual device available for investigation? no. Did we [mfr] replace the device? yes. Did pt have a backup they were able to switch to? yes. Was the pt able to successfully continue their infusion? yes. Is the infusion life-sustaining? yes. Outcome? resolved. Pt was sent extra cassette for this fill. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCASSETTE RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11093599
MDR Text Key224527466
Report NumberMW5098556
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 12/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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