FDA Adverse Event
Malfunction
Summary report: N
MRIDIUM INFUSION PUMP
MDR report key: 9399146
·
Received December 2, 2019
Report
- Report Number
- 3005053560-2019-00004
- Event Type
- Malfunction
- Date Received
- December 2, 2019
- Date of Event
- October 26, 2019
- Report Date
- December 2, 2019
- Manufacturer
- IRADIMED CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K090087
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
IRADIMED HAS REQUESTED THE PRODUCT FOR EVALUATION, AND THE HOSPITAL HAS SENT THE PRODUCT FOR IRADIMED'S EXAMINATION. THE DEVICE IS PRESENTLY IN TRANSIT TO THE MANUFACTURER. REPORTER HAS PERFORMED THE MANUFACTURER'S DEVICE PREVENTIVE MAINTENANCE TEST, AND DEVICE PASSED THESE TESTS. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE PRODUCT HAS BEEN EXAMINED BY IRADIMED CORPORATION.
Description of Event or Problem · 1
DURING AN MRI INFUSION OF PHENYLEPHRINE, AN ADULT PATIENT MAY HAVE RECEIVED EXCESS FLUID DUE TO A FREEFLOW CONDITION. MEDICAL INTERVENTION OCCURRED FOLLOWING THE EVENT, AND PATIENT RECOVERED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1193840 | MRIDIUM INFUSION PUMP | INFUSION PUMP | FRN | IRADIMED CORPORATION | 3861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |