FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 228602
·
Received June 18, 1999
Report
- Report Number
- 6000001-1999-00387
- Event Type
- Malfunction
- Date Received
- June 18, 1999
- Date of Event
- April 30, 1999
- Report Date
- May 3, 1999
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PUMP REPORTED TO GO INTO A FAILURE CODE 804:24 FOLLOWED BY A 38:309:1949:0002 A FEW SECONDS LATER, DURING PT USE. THE PUMP REPORTEDLY STOPPED ALL CHANNELS AND ALARM. NEOSENEPHRINE, DIPROVAN, AND D52 1/2 NORMAL SALINE WITH KCL WERE RUNNING AT THE TIME. THE PT'S B/P DROPPED TO 50/20. THE PT WAS GIVEN A SOLUTION BOLUS AND SWITCHED TO LEVOPHED. THE CLINICIAN REPORTED THAT SHE "ALMOST DID NOT GET HIM BACK." THE PT RETURNED TO PRE-INCIDENT STATUS, BUT THE CLINICIAN REPORTED "BARELY." NO PT INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | COLLEAGUE 3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |