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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM INFUSION SET

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IRADIMED CORPORATION MRIDIUM INFUSION SET Back to Search Results
Model Number 1056
Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Iradimed has received the product for evaluation, and the investigation is in process. A follow up report will be provided after the product investigation has been completed by iradimed corporation. (b)(4).
 
Event Description
During an mri infusion of levophed, the nurse reported patient called her into the mr scanner room to inform her the iv set being used was leaking. The nurse described that the infusion set had a 5 cm tear in the silicone pump chamber tubing. No information was provided as to the source of the tear in the tubing. The infusion set was quickly replaced to continue the infusion. The patient's blood pressure initially dropped, but recovered when the infusion set was replaced. No patient injury was reported.
 
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Brand NameMRIDIUM INFUSION SET
Type of DeviceINFUSION SET
Manufacturer (Section D)
IRADIMED CORPORATION
1025 willa springs drive
winter springs FL 32708 5235
Manufacturer (Section G)
IRADIMED CORPORATION
1025 willa springs drive
winter springs FL 32708 5235
Manufacturer Contact
francis casey
1025 willa springs drive
winter springs, FL 32708-5235
4076778022
MDR Report Key8810096
MDR Text Key151735742
Report Number3005053560-2019-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model Number1056
Device Catalogue Number1056
Device Lot Number19A16N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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