FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1872220
·
Received October 14, 2010
Report
- Report Number
- 6000030-2010-07974
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- September 7, 2010
- Report Date
- July 31, 2025
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S PUMP DEVICE HAD A VOLUME DISCREPANCY. AT REFILL, IT WAS EXPECTED DEVICE WOULD CONTAIN 7.9ML; PUMP INSTEAD CONTAINED 16ML. THE PATIENT'S HEALTH CARE PROVIDER (HCP) PERFORMED DYE AND ROTOR TESTS. IT WAS STATED THE CATHETER WAS "FINE," BUT THE ROTOR STUDY REVEALED A MOTOR STALL. THE PATIENT'S HCP STATED THEY WOULD REMOVE THE PATIENT'S DEVICE. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 | Male | Hospitalization |