FDA Adverse Event Injury Summary report: N

MEDITECH, MAGIC BBK MODULE

MDR report key: 123861 · Received September 30, 1997

Report

Report Number
1222805-1997-00007
Event Type
Injury
Date Received
September 30, 1997
Date of Event
September 18, 1997
Report Date
September 19, 1997
Manufacturer
MEDITECH
Product Code
MMH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON 09/19/1997 IT WAS REPORTED TO A MEDITECH REPRESENTATIVE THAT A PATIENT SUFFERED A DELAYED SEROLOGICAL TRANSFUSION REACTION TO ANTI-E DUE TO THE LACK OF HISTORICAL BLOOD BANK INFORMATION IN THE NEWLY CONVERTED BLOOD BANK SYSTEM. THE PATIENT INVOLVED HAD BEEN IN THE HOSPITAL IN 07/1997 AND AT THAT TIME, ANTI-E WAS IDENTIFIED AND ENTERED INTO THE OLD DATABASE. ON 09/12/1997, ANOTHER SPECIMEN WAS OBTAINED AND THE ANTIBODY SCREEN PERFORMED ON THIS SPECIMEN WAS NEGATIVE. SINCE THE ANTIBODY SCREEN WAS NEGATIVE AND NO HISTORICAL BLOOD BANK INFORMATION WAS IN THE NEW BLOOD BANK DATABASE, ONLY AN IMMEDIATE SPIN CROSSMATCH WAS PERFORMED ON THE UNITS TO BE TRANSFUSED TO THE PATIENT. THE UNITS WERE LATER TRANSFUSED TO THE PATIENT WITHOUT ANY APPARENT CLINICAL PROBLEMS. ON 09/18/1997, AN ADDITIONAL SPECIMEN WAS OBTAINED IN ORDER TO CROSSMATCH ADDITIONAL UNITS TO THE PATIENT. AN ANTIBODY SCREEN WAS PERFORMED ON THE NEW SPECIMEN AND FOUND TO BE POSITIVE. AT THIS TIME, THE USER FACILITY BECAME AWARE OF THE FACT THAT THE PATIENT HAD SUFFERED A DELAYED SEROLOGICAL TRANSFUSION REACTION. UPON FURTHER INVESTIGATION, THEY DISCOVERED THAT THE TRANSFUSION REACTION WAS DUE TO ANTI-E. THE USER FACILITY REPORTED THAT THEY WERE NOT AWARE OF ANY OTHER OCCURRENCES OF THIS SITUATION WITH OTHER PATIENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDITECH, MAGIC BBK MODULE SOFTWARE INFORMATION SYSTEM MMH MEDITECH V4.5 N/A NO SERIAL # IS ASSIGNED

Patients

Seq Age Sex Outcome Treatment
1 77 YR Life Threatening