FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1823566
·
Received August 27, 2010
Report
- Report Number
- 6000030-2010-06518
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 29, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A PUMP VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESIDUAL VOLUME, 17.0 ML, WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME, 4.8 ML. THE PATIENT EXPERIENCED AN UNDERDOSE AND REPORTED INCREASED PAIN. THE PUMP CONTAINED DILAUDID AT A CONCENTRATION OF 30 MG/ML BUT THE DOSAGE WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | CATHETER: MODEL 8709, LOT# J11614R63| IMPLANTED:| EXPLANTED: |