FDA Adverse Event
Injury
Summary report: N
CAREFUSION
MDR report key: 6194069
·
Received December 20, 2016
Report
- Report Number
- MW5066828
- Event Type
- Injury
- Date Received
- December 20, 2016
- Report Date
- December 20, 2016
- Manufacturer
- CAREFUSION
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS TRANSFERRED TO ED AT (B)(6) FROM AN OUTLYING HOSPITAL IN DIC WITH SEPTIC SHOCK ON (B)(6) 2016. BABY WAS (B)(6) BORN VIA NSVD TO GBST MOTHER. BABY WAS GIVEN ANTIBIOTICS AND PLACED ON ECMO ON (B)(6) 2016. PT WAS PLACED ON TPN VIA CAREFUSION ALARIS PUMP. THE PT RECEIVED 364 ML OVER 3 HOURS INSTEAD OF 24 HOURS. THE CHARGE NURSE AND THE NURSE EDUCATOR CHECKED THE PUMP AND IT APPEARED TO BE PROGRAMMED APPROPRIATELY FOR 1 ML PER HOUR. THE CAUSE OF THE PROBLEM REMAINS UNKNOWN AT THIS TIME. A REPORT HAS BEEN REQUESTED FROM THE COMPANY AND THE PUMP, ETC HAVE BEEN SENT TO ECRI FOR THE EVALUATION. THE PT DID EXPIRE BUT IT IS NOT THOUGHT TO BE ATTRIBUTABLE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 839586 | CAREFUSION | IV PUMP | FRN | CAREFUSION | BRAIN PCU-8015 | ||
| 839587 | CAREFUSION | IV PUMP | FRN | CAREFUSION | PUMP LVP-8120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |