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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS; SET, ADMINISTRATION, INTRAVASCULAR
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ACCESS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Tachycardia (2095)
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A patient experienced an over infusion of norepinephrine with use of an unknown access set which resulted in supraventricular tachycardia.It was reported that the medication was discontinued; however, the medication bag was left hanging on the intravenous pole, the tubing was left connected to the patient and in the pump.It was further reported, a nurse "utilizing interoperability to infuse an antibiotic inadvertently scanned the channel that had the discontinued the norepinephrine infusion".This resulted in the norepinephrine infusion restarting, and the patient received 75 ml from the 4 mg/250 ml bag over 45 minutes.The patient required medical treatment to resolve the issue.No additional information is available.
 
Manufacturer Narrative
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ACCESS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12513134
MDR Text Key272706924
Report Number1416980-2021-05850
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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