FDA Adverse Event Death Summary report: N

LIFESHIELD MICROBORE SET

MDR report key: 558050 · Received December 2, 2004

Report

Report Number
9613251-2004-00156
Event Type
Death
Date Received
December 2, 2004
Date of Event
October 2, 2004
Report Date
November 8, 2004
Manufacturer
HOSPIRA, LTD
Product Code
FPK
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MS, US

Narratives

Description of Event or Problem · 1

USER FACILITY MANDATORY MEDWATCH RECEIVED, WHICH STATED THE FOLLOWING: "THE PT WAS PREPARED FOR AN ABDOMINAL CT SCAN FOR RECTAL BLEEDING, WHICH REQUIRED AN INDWELLING IV CATHETER AND EXTENSION TUBING TO BE PLACED. THE PT WAS NOT RECEIVING IV FLUIDS OR MEDICATIONS AT THE TIME. THE PT'S BLOOD PRESSURE WAS BEING MONITORED WHILE WAITING TO HAVE THE CT SCAN. THE HOSE TO THE CUFF WAS DISCONNECTED AND THE CUFF REMAINED ON THE PT'S ARM WHENEVER THE PT WENT TO THE RESTROOM. AFTER THE SECOND RETURN FROM THE RESTROOM, THE PT WAS LEFT ALONE. THE PT'S SPOUSE RETURNED AND FOUND THE PT BLUE FROM THE NECK UP. CPR WAS IMMEDIATELY INITIATED. A SECOND NURSE IN THE ROOM DISCOVERED THAT THE BLOOD PRESSURE MONITORING HOSE HAD BEEN ATTACHED TO THE EXTENSION SET/INDWELLING CATHETER SET-UP. THE FIRST NURSE REPORTEDLY DID NOT CONNECT THE BLOOD PRESSURE MONITORING HOSE TO THE PT'S IV EXTENSION TUBING. THE PT RECEIVED APPROX 15 CC'S OF AIR THROUGH THE CATHETER CAUSING RESPIRATORY ARREST AND DEATH. A REPORT WAS FILED WITH THE POLICE AND AN AUTOPSY WAS PERFORMED. THE RESULTS CONFIRMED DEATH FROM AN AIR EMBOLISOM." UPON FURTHER QUERY THE FOLLOWING INFO WAS PROVIDED: IT IS BELIEVED THAT THE PT REMOVED THEMSELVES FROM THE EKG MONITOR & DISCONNECTED THE BLOOD PRESSURE CUFF IN ORDER TO GO TO THE BATHROOM. IT IS UNK AS TO WHO RECONNECTED THE EKG LEADS & BLOOD PRSSURE CUFF. THE MONITOR WAS SET ON AUTOMATIC WITH AN UNSPECIFIED FREQUENCY OF BLOOD PRESSURE MEASUREMENT. IT WAS REPORTED THAT CPR WAS PERFORMED WITHIN 30 MINUTES WITHOUT SUCCESS. DURING CPR, A MD INSERTED AN ARTERIAL LINE & REPORTEDLY RECEIVED AIR BACK. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFESHIELD MICROBORE SET ADMINISTRATION SET FPK HOSPIRA, LTD * 18052NS

Patients

Seq Age Sex Outcome Treatment
1 65 YR Death DATASCOPE CORP.| PASSPORT 2 MONITOR BLOOD PRESSURE HOSE MFG BY| BLOOD PRESSURE MONITOR MFG BY DATASCOPE CORP.