inforMED
MalfunctionFRR

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

Received Jun 23, 2006 · Event occurred May 25, 2006

Report 6000001-2006-13379 · MDR key 736797

Device

Generic name

Infusion Pump

Manufacturer

Baxter Healthcare

Model number

6201

Catalog number

2M8063

Lot number

NA

Product problems

  • Component(s), broken

Patient

NA

  • No Patient Involvement

Narrative

Description of Event or Problem

THE BAXTER TECH REPORTED A BROKEN DOOR FOUND DURING SVC. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. NO ADD'L INFO IS AVAILABLE.

Additional Manufacturer Narrative

EVAL SUMMARY: THE PUMP WAS EVALUATED BY A BAXTER SVC TECH. THE REPORTED CONDITION WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN REC'D FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.