MAUDE Adverse Event Report: SET, ADMINISTRATION, INTRAVASCULAR

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.

• Brand Name: SET, ADMINISTRATION, INTRAVASCULAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 10777832
• MDR Text Key: 214545328
• Report Number: MW5097613
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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 Number: 1
• Patient Age: 26 YR