Health product recall

IntelliVue -Information Centre iX - Software, IntelliBridge System (2019-05-05)

Starting date:
May 5, 2019
Posting date:
May 17, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69972

Last updated: 2019-05-17

Affected Products

A. IntelliVue -Information Centre iX - Software
B. IntelliBridge System

Reason

Data from the B. Braun Space LAN or arcomed UniQueDOC infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patient's chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values. Only the HL7 output from the Patient Information Center iX is affected. This problem only happens when the PIC iX or IBS is configured for regional settings in which a comma is used as the decimal separator.

For example, a pump delivering medication at 5.00 cc shows 500.00 cc in the patient's chart or electronic medical record (EMR).

Affected products

A. IntelliVue -Information Centre iX - Software

Lot or serial number

All lots.

Model or catalog number

M3290B

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES

B. IntelliBridge System

Lot or serial number

All lots.

Model or catalog number

866417

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES