FDA Adverse Event
Malfunction
Summary report: N
SMARTPUMP DUAL CHANNEL
MDR report key: 1232171
·
Received November 4, 2008
Report
- Report Number
- 1811755-2008-00082
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 10, 2008
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KCY
- PMA / PMN Number
- K924273
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE QUALITY ENGINEER, THERE WAS NO PROBLEM FOUND UPON INVESTIGATION DURING REPAIR.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BIER BLOCK PROCEDURE, THE PROXIMAL CUFF REMAINED INFLATED, BUT THE PRESSURE WAS NOT SUFFICIENT TO COMPLETELY PREVENT BLOOD FLOW. THE ANESTHESIOLOGIST INJECTED HALF THE AMOUNT OF LOCAL ANESTHESIA AS A RESULT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPUMP DUAL CHANNEL | PNEUMATIC TOURNIQUET | KCY | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |