FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE
MDR report key: 2233409
·
Received September 2, 2011
Report
- Report Number
- 6000001-2011-22383
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- June 15, 2011
- Report Date
- August 12, 2011
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K041191
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS DEVICE WAS NOT SENT TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED NOR CAN AN ASSIGNABLE CAUSE BE PROVIDED. SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
MEDWATCH NOTIFICATION SENT FROM GPV WAS RECEIVED IN THE CORPORATE MAILBOX. CUSTOMER REPORTED "VERSED 100MG/100ML 0.9 NS INFUSED INTRAVENOUSLY TO A PATIENT IN 3 HOURS WHEN DEVICE WAS PROGRAMMED TO DELIVER THE SOLUTION OVER 10 HOURS. PATIENT RECEIVED 200MG OF THE DRUG INSTEAD OF THE PRESCRIBED 55MG" . THIS OCCURED WITH A COLLEAGUE 3 CX CHANNEL C PUMP. THE USER INTERFACE SOFTWARE VERSION IS CURRENTLY UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |