FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2223865
·
Received August 18, 2011
Report
- Report Number
- 6000030-2011-06540
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- March 22, 2005
- Report Date
- July 25, 2011
- Manufacturer
- RICE CREEK MFG.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD AN OVERDOSE. PER REPORTER "DURING AN INITIAL REFILL WITH PREVIOUS PUMP A NURSE GAVE TOO MUCH MEDICATION." THE DRUG INFUSED WAS NOT KNOWN. THE CURRENT PUMP WAS WORKING AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MFG. | 8626-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703, LOT# J94132984 |