FDA Adverse Event
Malfunction
Summary report: N
CHILI PUMP AND TUBING
MDR report key: 3242465
·
Received April 8, 2013
Report
- Report Number
- 3242465
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 8, 2013
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LPB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
WHEN USING THE CHILLI PUMP TUBING, THE CHILLI PUMP ROTATED THE TUBING SO THAT IT PULLED THE SYRINGE SIDE INTO THE MACHINE AND THE SYRINGE ATTACHMENT BROKE. USING A NEW TUBING SET, THE MACHINE CONTINUED TO PULL THE TUBING INTO THE MACHINE AND HAD TO BE STOPPED AND ADJUSTED 3 TIMES BEFORE THE TUBING STAYED IN PLACE DURING PUMPING. NO HARM TO THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144603 | CHILI PUMP AND TUBING | ABLATION SYSTEM PUMP TUBING | LPB | BOSTON SCIENTIFIC | 2104 | 61258147 | |
| 144743 | CIRCUCOOL | CARDIAC ABLATION SYSTEM PUMP | LPB | BOSTON SCIENTIFIC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |