FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 483183
·
Received September 9, 2003
Report
- Report Number
- 6000030-2003-00811
- Event Type
- Injury
- Date Received
- September 9, 2003
- Date of Event
- August 9, 2003
- Report Date
- August 13, 2003
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HCP REPORTED PT WAS OVERDOSED. THE PUMP WAS IMPLANTED IN 2003, PROGRAMMED, AND THE PT WENT TO THE RECOVERY UNIT WITHOUT INCIDENCE. THE NEXT DAY THE PT WAS DISCHARGED AND WENT HOME. THE PT WENT INTO RESPIRATORY ARREST AND WAS ADMITTED TO THE HOSP INTENSIVE CARE UNIT WHERE THE PT WAS INTUBATED. PHYSICIAN STATED TO THE PUMP MFR'S REP THAT THE PT WAS OVERDOSED DUE TO A PHYSICIAN PROGRAMMING ERROR. A FOLLOW UP REPORT WILL BE SENT IF ADD'L INFO IS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization | CATHETER MODEL 8709 LOT# J11577R35 IMPLANTED: 2003| EXPLANTED: UNK. |