FDA Adverse Event
Malfunction
Summary report: N
CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON
MDR report key: 1220772
·
Received October 31, 2008
Report
- Report Number
- 6000001-2008-00691
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- September 30, 2008
- Report Date
- October 7, 2008
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- MEA
- PMA / PMN Number
- K051253
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN RECEIVED AT THE MFG FACILITY, HOWEVER, THE COMPLAINT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE NATIONAL COMPLAINT COORDINATOR (NCC) FOR INTN'L AFFILIATE RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING THE PT CONTROL MODULE (PCM). ACCORDING TO THE FACILITY, THE DEVICE OVER-INFUSED DURING PT USE. THE DEVICE WAS FILLED WITH A TOTAL FILL VOLUME OF 96ML OF 0.2% ROPIVACAINE HYDROCHLORIDE HYDRATE, MORPHINE HYDROCHLORIDE, AND DROLEPTAN. THE FACILITY REPORTED THAT INFUSION OF DRUG COMPLETED IN 24 HOURS. THERE WAS NO ADVERSE PT OUTCOME, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THE ALLEGED INCIDENT. NO FURTHER INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CE 2 ML PATIENT CONTROL MODULE SINGLE PACK 6/CARTON | 80MEA | MEA | BAXTER HEALTHCARE CORP. | 08C048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |