FDA Adverse Event Malfunction Summary report: N

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

MDR report key: 558870 · Received May 4, 2004

Report

Report Number
6000001-2004-00790
Event Type
Malfunction
Date Received
May 4, 2004
Date of Event
April 1, 2004
Report Date
April 13, 2004
Manufacturer
BAXTER HEALTHCARE PTE. LTD.
Product Code
FRN
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

THE FACILITY'S BIOMED REPORTED THE PUMP WAS INVOLVED IN AN INFILTRATION DURING PT USE. THE PT WAS RECEIVING AN IV OF VANCOMYCIN WHEN THE NURSE NOTICED AT THAT LOCATION OF THE INFUSION SITE, THERE WAS A SOFTBALL SIZE BUBBLE OF MEDS THAT DID NOT INFUSE INTO THE PT'S VEIN. THE NURSE STOPPED THE INFUSION, PLACED A WARM COMPRESS ON THE SITE, AND RAISED THE PT'S ARM TO ALLOW THE FLUID TO ABSORB INTO THE PT'S SYSTEM. THE NURSE REPLACED THE SET UP WITH A NEW SET UP AND CONTINUED WITH THE THERAPY. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER TO OBTAIN ADDITIONAL INFO FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PT STATUS, PT INJURY, AGE OF PT, MEDICATION INVOLVED, OR THE SETUP OF THE INFUSION DEVICE. THE HOSP REP STATED THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVING THE PUMP SINCE THE LAST BAXTER SERVICE EVENT. NO ADDITIONAL CONTACT INFO WAS PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6201 NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN