FDA Adverse Event
Other
Summary report: N
IV PUMP
MDR report key: 19429614
·
Received May 29, 2024
Report
- Report Number
- MW5155598
- Event Type
- Other
- Date Received
- May 29, 2024
- Manufacturer
- BD / CAREFUSION 303, INC.
- Product Code
- FRN
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PATIENT RECEIVED AN ENTIRE 25,000 UNIT/250 ML BAG OF HEPARIN OVER 74 MINUTES. PROGRAMMED RATE ON PUMP WAS 12.3 ML/HR (12 UNITS/KG/H). PUMP PROGRAMMING WAS VALIDATED AT TIME OF RECOGNITION OF BOLUS (NURSE MANAGER CONFIRMED). PUMP AND IV TUBING WAS SEGREGATED AND TAGGED FOR BIOMED. BIOMED PERFORMED TESTING AND COULD NOT FIND REASON FOR BOLUS. MED SAFETY NURSE SPECIALIST CONFIRMED PROGRAMMING WAS CORRECT VIA KNOWLEDGE PORTAL {BD WEBSITE). IV PUMP SENT TO MANUFACTURER (BD ALARIS) FOR FURTHER INVESTIGATION AND REASON FOR ERROR WAS NOT IDENTIFIED. SUBMISSION ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329817 | IV PUMP | PUMP, INFUSION | FRN | BD / CAREFUSION 303, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | IV TUBING. |