FDA Adverse Event
Other
Summary report: N
ON-Q PAINBUSTER
MDR report key: 1914391
·
Received November 18, 2010
Report
- Report Number
- 2026095-2010-00280
- Event Type
- Other
- Date Received
- November 18, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 19, 2010
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- PMA / PMN Number
- K063530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR EVAL AND INVESTIGATION, BUT HAS NOT YET BEEN RECEIVED. WITHOUT THE ACTUAL PRODUCT, THE ANALYSIS IS LIMITED. AN INVESTIGATION IS BEING CONDUCTED. A SUPPLEMENTAL REPORT WILL BE FILED AT THE CONCLUSION TO THE INVESTIGATION. INFO PROVIDED LATER BY THE CUSTOMER INDICATED THAT THE PRODUCT CODE MAY ACTUALLY BE A PS12505, BUT THE LOT NUMBER PROVIDED IS FOR THE PRODUCT PS12503, WHICH IS NOT A DUAL CATHETER PUMP. MORE INVESTIGATION WILL BE CONDUCTED TO TRY AND CLARIFY THE ACTUAL COMPLAINT AND THE PRODUCT INVOLVED.
Description of Event or Problem · 1
PUMPS ARE INFUSING TOO FAST. ONE PT HAD 2 PUMPS. LEFT PUMP 21.5ML/52.75 HOURS; RIGHT PUMP 12.5ML/52.75 HOURS. TOTAL 34ML/52.75 HOURS. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q PAINBUSTER | ELASTOMERIC PUMP | MEB | I-FLOW CORP. | PS12503 | 032658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |