FDA Adverse Event
Malfunction
Summary report: N
PLUM 360 DRIVER NEW
MDR report key: 9532461
·
Received December 30, 2019
Report
- Report Number
- 9615050-2019-00482
- Event Type
- Malfunction
- Date Received
- December 30, 2019
- Date of Event
- November 22, 2019
- Report Date
- December 6, 2019
- Manufacturer
- ICU MEDICAL COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K141789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
H10: RECEIVED THE PLUM 360 PUMP LN 30010-04-05 SN (B)(4) ON JANUARY 2, 2020 FOR INVESTIGATION. THE PUMP WAS TESTED WITH THE NON-SERIALIZED DEVICES LISTED IN THE COMPLAINT. COULD NOT CONFIRM CUSTOMER'S COMPLAINT THAT THE PUMP HAS AN AIR TRAVELED THROUGH CASSETTE INTO DISTAL SIDE OF THE LINE. PROBABLE CAUSE NOT FOUND.
Additional Manufacturer Narrative · 1
POSSIBLE LOT NUMBERS FOR THE CONCOMITANT PLUM SET (4102122, 4015857, 4099967, 4099959). THE DEVICE WAS RECEIVED FOR INVESTIGATION, HOWEVER, IT IS NOT YET COMPLETE.
Description of Event or Problem · 1
THE EVENT INVOLVED A PLUM 360 DEVICE THAT ALLOWED AIR TO TRAVEL THROUGH THE CASSETTE TO THE DISTAL SIDE OF THE LINE AND THE EVENT WAS NOT NOTED IN THE DEVICE HISTORY LOG. THERE WAS NO REPORT OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1327843 | PLUM 360 DRIVER NEW | PUMP, INFUSION | FRN | ICU MEDICAL COSTA RICA LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PLUM SET, MFR ICU MEDICAL |