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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SET, ADMINISTRATION, INTRAVASCULAR

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SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Infusion or Flow Problem (2964)
Patient Problems Chest Pain (1776); Dyspnea (1816); Pain (1994)
Event Date 09/17/2020
Event Type  Injury  
Event Description
Home health nurse reported that on (b)(6) 2020 with 40 minutes left to finish the infusion, patient felt back pain, chest pain, shortness of breath. Nurse administered epipen (one pen) for infusion related event and after 10-15 minutes patient felt normal. In addition: rn above reported that there was a message on the pump that said, "unable to infuse" and they gave the dose via gravity infusion. Pt did not miss a dose; unknown lot / expiration of curlin pump; pump is available for return. Adverse event is related to the infusion, not the pump. No further information known. Reported to (b)(6) by health professional.
 
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Brand NameSET, ADMINISTRATION, INTRAVASCULAR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key10777832
MDR Text Key214545328
Report NumberMW5097613
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 09/17/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received11/02/2020
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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