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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 Failure to Disconnect (2541)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2021
Event Type  Injury  
Event Description
Spontaneous call from (b)(6) from md office, who reports that patient had to go to emergency room at the beginning of (b)(6) 2021 because she was unable to detach or unscrew a component of her infusion to change cassettes.No information available on what component was causing issue or if it was patient error.The issue is not related to the pump itself.Patient being seen in office today to discuss.No other information available.Did the reported product fault occur while in use with the patient? unknown.Did the product issue cause or contribute to patient or clinical injury? unknown.If yes, was any medical intervention provided? yes, pt went to er.Is the actual device available for investigation? unknown.Did we replace device? unknown.Did the patient have a backup device they were able to switch to? unknown.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved? ongoing? resolved.Reported to (b)(6) by health professional.
 
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Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11759916
MDR Text Key248792578
Report NumberMW5101102
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 04/28/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Age31 YR
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