inforMED
MalfunctionFPK

LS LF REG EXT SET NON-DEHP

Received Sep 5, 2014 · Event occurred Jan 1, 2014

Report 9613251-2014-00135 · MDR key 4098908

Device

Generic name

80fpk

Manufacturer

Hospira Ltd.

Model number

NA

Catalog number

20667

Lot number

UNK4W

Product problems

  • Insufficient Flow or Under Infusion

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem

GENERAL COMPLAINT OF AN UNDOCUMENTED NUMBER OF INCIDENTS OF UNDER DELIVERY. THE DEVICES WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES. THE CUSTOMER CONTACT INDICATED THAT THE NURSE REPORTED THAT THE DEVICES ARE RUNNING SLOW. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO ANY PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFO WAS PROVIDED.