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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD -EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD -EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Type  Injury  
Event Description
Spontaneous call. Spoke with patient who stated that she had fever and infection, and she made mistake and used one of the new cassettes, so she currently has an expired cassette. Informed patient to discard the cassette that is expired and continue using the new cassettes for infusion. Patient also mentioned that she is having problems with her extension set tubing. She had leakage twice last week through the filter, but the leakage stopped when she replaced the tubing. No other information provided at this time. Extension set lot number and expiration date not provided. Did the reported product fault occur while in use with the patient? yes, did the product issue cause or contribute to patient or clinical injury? no, infection and fever was, before the leakage problem end not related. If yes, was any medical intervention provided? no, infection and available for investigation? no, did we [mfr] replace the tubing? yes, did the patient have additional tubing they were able to switch to? yes, if was, the patient able to successfully continue their infusion? yes, if no, what was she patient instructed to do in able to continue their infusion? n/a, is the infusion life-sustaining? yes. What is the outcome of the event? resolve. Resolved? yes, ongoing? n/a. Reported to (b)(6) bypatient/ caregiver.
 
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Brand NameCADD -EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12518612
MDR Text Key273302126
Report NumberMW5104160
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 09/20/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
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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