FDA Adverse Event Malfunction Summary report: N

SMART SITE, ALARIS MEDICAL SYSTEMS, SAN DIEGO, CA

MDR report key: 376498 · Received February 9, 2002

Report

Report Number
MW1024063
Event Type
Malfunction
Date Received
February 9, 2002
Report Date
February 9, 2002
Manufacturer
SMART SITE, ALARIS MEDICAL SYSTEMS
Product Code
FPA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

AVOID SIMILAR CONNECTIONS ON INTRAVENOUS SETS AND BLOOD PRESSURE CUFFS. AS NEW PRODUCTS ARE INTRODUCED NOVEL POTENTIAL PROBLEMS MAY BE NOTED. HOSP SYSTEM RECENTLY CHANGED INTRAVENOUS IV TUBING SYSTEMS TO A SET WITH VALVE PORTS (SMART SITE). THESE SETS HAVE FEMALE LUER LOCK VALVE PORTS AND COMPLY WITH NEEDLE FREE PROTOCOLS. RPTR FINDS THAT THE IV VALVE PORTS (ESPECIALLY WHEN FILLED WITH PROPOFOL) ARE SIMILAR IN APPEARANCE TO THE FEMALE LUER LOCK CONNECTOR AND TUBING OF HOSP'S BLOOD PRESSURE CUFFS (CLASSIC CUF, CRITIKON). INDEED THE NON-INVASIVE BLOOD PRESSURE (NIBP) INFLATION HOSE CAN BE CONNECTED DIRECTLY INTO THE IV PORT. ACTIVATING NIBP -AS/3, DATEX-OHMEDA, IN THIS CASE WOULD DELIVER APPROXIMATELY 900CC OF AIR OVER 20 SECS INTRAVENOUSLY, POTENTIALLY CAUSING SERIOUS INJURY OR DEATH. INSERTING A NIBP INFLATION HOSE INTO AN IV VALVE PORT SEEMS LIKE AN UNLIKELY MISTAKE. YET IN A RUSHED SITUATION, A DARKENED ROOM, OR WHEN USED BY INEXPERIENCED PERSONNEL IT COULD CONCEIVABLY HAPPEN. RPTR WOULD SUGGEST THAT THE COMBINATION OF FEMALE LUER LOCK PORTS ON BOTH IV TUBING AND NIBP CUFFS SHOULD BE AVOIDED TO PREVENT THE POSSIBILITY OF CATASTROPHIC AIR EMBOLISM. PERHAPS A DIFFERENT NON-COMPATIBLE STANDARD FOR NON-IV LUER CONNECTIONS COULD BE USED, THEREBY PREVENTING MISTAKEN ATTACHMENT TO AN IV SET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SMART SITE, ALARIS MEDICAL SYSTEMS, SAN DIEGO, CA IV SET FPA SMART SITE, ALARIS MEDICAL SYSTEMS * *

Patients

Seq Age Sex Outcome Treatment
1 *