FDA Adverse Event
Malfunction
Summary report: N
DYONICS 25 INFLOW/OUTFLOW TUBING SET
MDR report key: 1070785
·
Received July 3, 2008
Report
- Report Number
- 1216828-2008-00005
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 29, 2008
- Report Date
- June 4, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT AND COULD NOT CONFIRM CUSTOMER COMPLAINT. NO PROBLEM FOUND. (B) (4).
Description of Event or Problem · 1
DURING SHOULDER PROCEDURE, THE PUMP WOULD NOT CALIBRATE PROPERLY, WATER KEPT RUNNING THROUGH AND PRESSURE WAS PULSATING IN THE SHOULDER. SHOULDER BECAME VERY SWOLLEN. ONCE THE CASSETTE WAS REPLACED THE PUMP RETURNED TO NORMAL. UNKNOWN PATIENT STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYONICS 25 INFLOW/OUTFLOW TUBING SET | DYONICS 25 | HRX | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 7211006 | 60989275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |