FDA Adverse Event Malfunction Summary report: N

ALARIS PCU

MDR report key: 19995497 · Received August 14, 2024

Report

Report Number
MW5158468
Event Type
Malfunction
Date Received
August 14, 2024
Report Date
August 11, 2024
Manufacturer
BD / CAREFUSION 303, INC.
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

LOGIC BOARD AND POWER BOARD OF CAREFUSION BD ALARIS HAVE SIGNIFICANT RATES OF FAILURE DUE TO FLUX/UNKNOWN CONTAMINATION AS A RESULT OF THE MANUFACTURING PROCESS. BRAND NEW UNITS LEAVE THE LINE, ENTER THE FIELD AND CANNOT START, RANDOMLY SHUT DOWN, HAVE NO POWER OR LOW POWER ALARMS AND THE ENGINEERING TEAMS HAVE NOT TRACED ANYTHING TO SPECIFIC COMPONENTS, RATHER TO THE MANUFACTURING CONTAMINATION AND THEY SAY REPLACE THE BOARDS WITH NEW BOARDS. THE REPLACEMENT BOARDS HAVE SIMILAR RATES OF CONTAMINATION. BD HAS TURNED THE CRITICAL COMPONENT OF LOGIC AND POWER BOARDS INTO A "BREAK/FIX" ISSUE AND IS NOT CONSIDERING THE RISK OF SENDING THESE DEVICES OUT WITH COMPROMISED BOARDS. THIS ISSUE IS INTERMITTENT AND NOT ALWAYS DISCERNIBLE IN THE FACTORY. SOMETIMES IT TAKES SEVERAL MONTHS IN THE FIELD FOR DEVICE TO RETURN WITH THE COMPLAINT HOWEVER ONCE IT DOES IT IS CLEAR UPON LOOKING AT THE LOGIC BOARD WHY IT WILL NOT START. ERRORS SUCH AS "MISSING STARTUP FILES", "WATCHDOG", AS WELL AS POWER SUPPLY ERRORS 121.2070 AMONG OTHERS. BD HAS OUTSOURCED BOARD MANUFACTURING TO CHIHUAHUA, MEXICO IN SEARCH OF LOWER LABOR COSTS HOWEVER SINCE THIS GRADUAL TRANSITION THE RATE OF FAILURES HAS RISEN DRAMATICALLY. FURTHER, THESE CRITICAL ERRORS BEING EXPERIENCED BY CUSTOMERS ARE NOT BEING REPORTED AND ESCALATED INTERNALLY PROPERLY. AN ISSUE LIKE "UNEXPECTED SHUTDOWN" SHOULD BE SENT STRAIGHT TO DCHU FOR INVESTIGATION HOWEVER DUE TO SHEER VOLUME OF COMPLAINTS AND THE "BREAK/FIX" PHILOSOPHY MANAGEMENT HAS EMBRACED IT IS SIMPLY NOT AND INSTEAD REPLACED WITH A SUSPECT BOARD. THIS MAY ALSO BE COMPOUNDED BY THE FACT THAT DCHU THEMSELVES HAS BEEN OUTSOURCED TO TIJUANA, MEXICO. THIS IS A MANUFACTURING DEFECT UNRELATED TO THE KNOWN ISSUE OF IMPROPERLY CALIBRATED EQUIPMENT AT THE IUI MANUFACTURER CAUSING MILLIONS OF REJECTED IUIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2350669 ALARIS PCU PUMP, INFUSION FRN BD / CAREFUSION 303, INC. 8015 BD

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown