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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IV LINE SET, ADMINISTRATION, INTRAVASCULAR

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IV LINE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Fluid Leak (1250); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Muscle Weakness (1967); Dizziness (2194)
Event Date 04/13/2021
Event Type  Injury  
Event Description
Spontaneously patient called and reported an issue with her pump (b)(4). She stated that she awoke around 4 am and was wet because her pump had been leaking. Patient had called the pharmacy earlier in the morning and was advised to make a new cassette and use backup pump, but patient stated that her husband mixes her cassettes, so she was going to call him to do so. Per patient this didn't occur till 11 am. Patient was potentially off her remodulin for an unknown period of time. It is unclear where the leak was occurring. Patient added that her iv line got tugged a few days ago and a few stitches fell out. Patient reports she is feeling somewhat weak and dizzy. Patient also reporting twitching in hands. Notified md office. No other information or dates available. If yes, was any medical intervention provided? no; is the actual device available for investigation? yes; did we[mfr] replace device? yes. Did the pt have a back up device they were able to switch to? yes. Was the pt able to successfully continue their infusion? yes. Is the infusion life-sustaining? yes. Outcome of 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? yes. If yes, was any medical intervention provided? no. Reported to (b)(6) by pt/caregiver.
 
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Brand NameIV LINE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key11693025
MDR Text Key246481097
Report NumberMW5100851
Device Sequence Number2
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 04/14/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
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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