FDA Adverse Event Malfunction Summary report: N

IVAC PRIMARY PUMP SET

MDR report key: 159671 · Received March 26, 1998

Report

Report Number
159671
Event Type
Malfunction
Date Received
March 26, 1998
Date of Event
February 1, 1998
Report Date
March 25, 1998
Manufacturer
ALARIS MEDICAL SYSTEMS, INC.
Product Code
FPA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THIS IS AN ANECDOTAL REPORT OF THE EVENTS THAT TOOK PLACE SURROUNDING THE DISCOVERY AND SUBSEQUENT IDENTIFICATION OF A PROBLEM THAT UF IS EXPERIENCING, AS A RESULT OF A CHANGE IN THE IVAC PRIMARY PUMP SET. OVER THE COURSE OF A FEW WEEKS, THE NUMBER OF REPORTED AIR IN THE LINE ALARMS WITH THE IVAC PUMPS APPEARED TO BE INCREASING. THE NURSES WERE REPORTING THAT THE IVAC PRIMARY PUMP SET (59-093) SECONDARY PORTS WERE CHANGED. THEY NOTICED A CHANGE IN THE COLOR OF THE DIAPHRAGM ON THE SECONDARY PORTS. THE NURSES ALSO REPORTED DIFFICULTY IN ACCESSING THESE PORTS WITH THE BLUNT BRAUN ACCESS PINS THAT UF IS USING. IN INVESTIGATING THESE REPORTS, THE LOCAL CO REPRESENTATIVE WAS CALLED, BUT NOT AVAILABLE. ON WEDNESDAY, FEBRUARY 18,1998, A CALL WAS PLACED TO THE "800" LINE (1-800-547-7828). A CO REPRESENTATIVE, RESPONDED TO THAT CALL. REP INFORMED UF THAT THE PORT HAD BEEN RE-ENGINEERED TO A LATEX-FREE PORT AND THAT HE BELIEVED THAT IT WAS NOT INTENDED FOR BLUNT NEEDLE USE. AT THIS POINT, HE INDICATED TO UF THAT ENOUGH SUPPLY OF THE "OLD" (PRE-JUNE 1997) TUBING SETS SHOULD BE AVAILABLE TO UF TO USE UNTIL SEPTEMBER, AN ANTICIPATED CHANGE DATE OF IV SUPPLIES FOR UF. SUBSEQUENT TO THAT CONVERSATION, UF'S PURCHASING CLERK ATTEMPTED TO ORDER PRE-JUNE 1997 LOTS BUT WAS UNABLE TO OBTAIN MORE THAN A ONE WEEK SUPPLY. THE SENIOR AREA MGR FOR ALARIS MEDICAL SYSTEM CAME TO THE HOSP ON FRIDAY, FEBRUARY 20, 1998, TO ADDRESS THE ISSUE. SINCE THE OLD STOCK WAS NOT AVAILABLE AND THE NEW DESIGN DID NOT WORK WITH UF'S NEEDLELESS SYSTEM, UF CONVERTED TUBING SETS SO THAT A BLUNT NEEDLELESS ACCESS PIN WAS NOT NECESSARY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 IVAC PRIMARY PUMP SET IV SET FPA ALARIS MEDICAL SYSTEMS, INC. * 59-093

Patients

Seq Age Sex Outcome Treatment
1 * BLUNT NEEDLELESS SYSTEM