FDA Adverse Event
Malfunction
Summary report: N
SMARTPUMP DUAL CHANNEL
MDR report key: 1860256
·
Received September 22, 2010
Report
- Report Number
- 1811755-2010-01232
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 26, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KCY
- PMA / PMN Number
- K924273
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE NOT HOLDING PRESSURE WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE PNEUMATIC ASSEMBLY, WHICH WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LEG SURGERY, THE TOURNIQUET PUMP WOULD NOT HOLD PRESSURE. THERE WAS SOME BLOOD LEAKAGE INTO THE SURGICAL SITE, BUT THERE WAS NO REPORTED INTERVENTION OR ADDITIONAL TREATMENT GIVEN DUE TO THIS EVENT.
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 |