FDA Adverse Event
Summary report: N
ONCOLOGY KIT WITH SPINNING SPIROS
MDR report key: 10777658
·
Received November 3, 2020
Report
- Report Number
- 10777658
- Date Received
- November 3, 2020
- Date of Event
- October 27, 2020
- Report Date
- October 30, 2020
- Manufacturer
- ICU MEDICAL INC
- Product Code
- FPA
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
CHEMOTHERAPY BEING PRIMED IN MEDICATION ROOM WITH SPIROS, C-CLIP, RED CAP (LOT 4962268; REF (B)(4)). THE SPIROS "CLICKED" ONTO THE TUBING, BUT THE C-CLIP WAS HAVING ISSUES "CLICKING." FIVE DIFFERENT TUBING AND SPIROS WERE TRIED. SINCE THE SPIROS "CLICKED," IT WAS DECIDED TO PRIME THE CHEMO. WHEN ATTACHING THE SPIROS TO THE CHEMOTHERAPY, IT STARTED TO BACK-PRIME AND LEAK OUT OF THE SPIROS. CHEMOTHERAPY RETURNED TO PHARMACY AND RESULTED IN A DELAY OF CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1243426 | ONCOLOGY KIT WITH SPINNING SPIROS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ICU MEDICAL INC | CH3581 | 4962268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1095 DA |