FDA Adverse Event
Malfunction
Summary report: N
UNSPECIFIED PUMP
MDR report key: 19957908
·
Received August 10, 2024
Report
- Report Number
- 9615050-2024-00596
- Event Type
- Malfunction
- Date Received
- August 10, 2024
- Date of Event
- July 1, 2024
- Report Date
- August 10, 2024
- Manufacturer
- ICU MEDICAL COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PLUM 360 HAD MULTIPLE PUMPS TURNED OFF WHILE ADMINISTERING CRITICAL DRIPS. THEY ARE ALSO NOT RECEIVING PUMPS THAT ARE DESIGNED FOR CRITICAL DRIPS. THIS IS AN ISSUE BECAUSE THE NCD PUMPS DO NOT AUDIBLY ALARM SO IF A PATIENT IS RECEIVING MAGNESIUM OR PITOCIN THIS COULD CAUSE PATIENT HARM. THERE WAS NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2515070 | UNSPECIFIED PUMP | PUMP, INFUSION | FRN | ICU MEDICAL COSTA RICA LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |