SYNCHROMED II
Report
- Report Number
- 3007566237-2013-02001
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 21, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
IT WAS LATER REPORTED THAT THERE WAS A CATHETER MALFUNCTION. THE PATIENT EXPERIENCED INCREASED PAIN. A DYE STUDY AND REVISION WAS DONE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID 400MG/ML AT 6.822/DAY.
IT WAS REPORTED THAT THE HCP WAS UNABLE TO WITHDRAW MORE THAN 0.1ML OF FLUID DURING A CATHETER DYE STUDY SO WAS NOT COMFORTABLE PUSHING CONTRAST THROUGH. THE CATHETER WAS NOT RE-PRIMED. THE CATHETER WAS FOLLOWED FROM THE PUMP UP TO THE TIP AND NOTHING SUSPICIOUS WAS SEEN. THE PATIENT WAS BEING REFERRED FOR A CATHETER REPLACEMENT.
IT WAS REPORTED THAT THE PATIENT HAD A CATHETER REPLACEMENT AND OTHER COMPLICATIONS IN THE PAST. THE FOLLOWING INFORMATION IS A SEPARATE EVENT AND WAS PREVIOUSLY REPORTED IN MANUFACTURER¿S REPORT #3004209178-2013-10256: [IT WAS REPORTED THAT THE HCP WAS UNABLE TO WITHDRAW MORE THAN 0.1ML OF FLUID DURING A CATHETER DYE STUDY SO WAS NOT COMFORTABLE PUSHING CONTRAST THROUGH. THE CATHETER WAS NOT RE-PRIMED. THE CATHETER WAS FOLLOWED FROM THE PUMP UP TO THE TIP AND NOTHING SUSPICIOUS WAS SEEN. THE PATIENT WAS BEING REFERRED FOR A CATHETER REPLACEMENT.]
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273753 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Required Intervention |