ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-31066
- Event Type
- Injury
- Date Received
- July 4, 2024
- Date of Event
- June 11, 2024
- Report Date
- September 19, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801549
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2717-2020
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.
OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: UNIQUE IDENTIFIER (UDI) # ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: IMDRF ANNEX A, B, C, D CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE REPORTED ISSUE ALLEGING AN INFUSION OF LEVOPHED (NOREPINEPHRINE) WAS FOUND TO HAVE STOPPED COULD NOT BE CONFIRMED BECAUSE THE REQUESTED DEVICES AND THE ASSOCIATED DEVICE LOGS WERE NOT PROVIDED TO BD FOR ANALYSIS. THE CAUSE FOR THE INFUSION STOPPING COULD NOT BE IDENTIFIED FOR THE SAME REASON, NO PRODUCT OR DEVICE LOGS WERE PROVIDED TO BD FOR ANALYSIS. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT AN INFUSION OF LEVOPHED (NOREPINEPHRINE) WAS FOUND TO HAVE STOPPED WAS NOT ABLE TO BE IDENTIFIED BECAUSE THE REQUESTED DEVICES AND THE ASSOCIATED DEVICE LOGS WERE NOT PROVIDED BY THE FACILITY FOR ANALYSIS.
IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE WITH SERIAL NUMBER# (B)(6) IS A CONCOMITANT AND THIS FILE HAS CAPTURED THE CORRECT SUSPECT DEVICE WITH SERIAL NUMBER# (B)(6) AS PER INVESTIGATION REPORT. OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: DESCRIBE EVENT OR PROBLEM, MEDICAL DEVICE CATALOG #, UNIQUE DEVICE IDENTIFIER (UDI) #, MEDICAL DEVICE SERIAL #, MEDICAL DEVICE MODEL #, CONCOMITANT MED PROD DATA, DEVICE MANUFACTURE DATE. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL? RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER? IMDRF ANNEX A, G, B, C, D CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # AND MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORTED ISSUE OF THE PUMP CEASING TO INFUSE LEVOPHED WAS CONFIRMED VIA LOG ANALYSIS AND IDENTIFIED A POWER INTERRUPTION OCCURRED WITH THE PUMP MODULE INFUSING. THIS PRODUCED A CHANNEL DISCONNECTED ALARM ON THE PCU STOPPING THE PUMP MODULE¿S INFUSION. THE INCIDENT WAS NOT REPLICATED DURING THE TESTING PROCESS. ON THE DATE (B)(6) 2024 AT THE TIME OF 11:16 07 AM, THE INFUSION OF LEVOPHED (NOREPINEPHRINE) ON CHANNEL ¿C" PUMP MODULE STOPPED DUE TO THE OCCURRENCE OF A CHANNEL DISCONNECT TO THE MODULE THE PCU DID ALARM WITH A ¿CHANNEL DISCONNECTED¿ MESSAGE TO THE USER UNTIL THE CONFIRM KEY WAS SELECTED TO STOP THE ALARM AT 12'48:34 PM. THE INSPECTION PROCESS FOUND THE PRESENCE OF ISOLATION RIB DAMAGE WITH THE 11TH PIN OF THE RIGHT INTER UNIT INTERFACE (IUI) CONNECTOR ON THE PCU EXHIBITING A CONTINUITY ISSUE ON THE PM. CHANNEL DISCONNECT REPLICATION TESTING COULD NOT BE PERFORMED AS RECORDED IN THE DEVICE EVENT LOGS BECAUSE THE PUMP MODULES (B)(6) WERE FOUND TO BE UNRESPONSIVE WHILE CONNECTED AT THE RIGHT SIDE OF THE PCU DUE TO THE LOSS OF COMMUNICATION BETWEEN THE PCU AND THE PUMP MODULES. THE DAMAGED RIGHT IUI CONNECTOR ON THE PCU WAS TEMPORARILY REPLACED, AND FURTHER TESTING FOUND THE SYSTEM TO OPERATING AS EXPECTED WITH NO FURTHER OCCURRENCE OF ¿CHANNEL DISCONNECTED¿ ALARMS OR HAVING ANY OTHER UNEXPECTED CONTINUITY ISSUES OCCUR AT THE RIGHT SIDE OF THE PCU. THE DAMAGED RIGHT IUI CONNECTOR AGE WAS NOTED TO BE OVER 12 YEARS OLD AND WAS AGED BEYOND IT¿S EXPECTED SEVEN-YEAR LIFE. ¿ IT WAS NOTED DURING THE INSPECTION PROCESS THAT A THIRD-PARTY PART WAS USED ON THE ALARIS SYSTEM. THE PART WAS NOT IDENTIFIED TO HAVE BEEN THE CONTRIBUTING FACTOR FOR THE REPORTED INCIDENT, HOWEVER, BELOW NOTES BD¿S POSITION ON THE USE OF THIRD-PARTY PARTS USAGE. ROOT CAUSE: THE PROBABLE CAUSE FOR THE REPORTED ISSUE THAT THE PUMP STOPPED INFUSING - LEVOPHED IS ATTRIBUTED TO THE OBSERVATIONAL FINDING OF ISOLATION RIB DAMAGE WITHIN THE CONTACT AREAS OF THE RIGHT INTER UNIT INTERFACE (IUI) CONNECTOR ON THE PCU THAT CAUSED A POWER INTERRUPTION TO THE PUMP MODULE INFUSING LEVOPHED (NOREPINEPHRINE). THE SYSTEM DID ALARM ¿CHANNEL DISCONNECTED" AS DESIGNED AND THE ALARM WAS CONFIRMED BY A USER PER THE RECORDED EVENT LOG DETAILS. BD HAD IDENTIFIED THE ROOT CAUSE FOR ISOLATION RIB DAMAGE ON THE IUI CONNECTOR PIN TO BE ASSOCIATED WITH USER ERROR. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A1801, G02017, C0601, D01 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
IT WAS REPORTED DURING AN INFUSION THE PUMP STOPPED INFUSING AND ALLEGEDLY DID NOT ALARM. ADDITIONAL INFORMATION PROVIDED: DURING A ROUTINE INFUSION OF LEVOPHED, THE PUMP REPORTEDLY STOPPED INFUSING. THE VOLUME TO BE INFUSED (VTBI) WAS 250ML, DRUG CONCENTRATION WAS 8MG/250ML. THE INTENDED RATE WAS "TITRATE AS NEEDED (PRN)". THE PATIENT REPORTEDLY BECAME HYPOTENSIVE WITH A BLOOD PRESSURE OF 68/32. THE CLINICIAN REPORTEDLY OBTAINED A NEW MODULE, TITRATED THE LEVOPHED, WHICH RAISED THE BLOOD PRESSURE. THE CUSTOMER STATED THE PATIENT "FULLY RECOVERED, NO LASTING IMPACT." OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT VIA SEPARATE PUMP MODULES WERE VANCOMYCIN 167ML/HR., POTASSIUM 41.7ML/HR., AND ZOSYN 25ML/HR.
IT WAS REPORTED DURING AN INFUSION THE PUMP STOPPED INFUSING AND ALLEGEDLY DID NOT ALARM. ADDITIONAL INFORMATION PROVIDED: DURING A ROUTINE INFUSION OF LEVOPHED, THE PUMP REPORTEDLY STOPPED INFUSING. THE VOLUME TO BE INFUSED (VTBI) WAS 250ML, DRUG CONCENTRATION WAS 8MG/250ML. THE INTENDED RATE WAS "TITRATE AS NEEDED (PRN)". THE PATIENT REPORTEDLY BECAME HYPOTENSIVE WITH A BLOOD PRESSURE OF 68/32. THE CLINICIAN REPORTEDLY OBTAINED A NEW MODULE, TITRATED THE LEVOPHED, WHICH RAISED THE BLOOD PRESSURE. THE CUSTOMER STATED THE PATIENT "FULLY RECOVERED, NO LASTING IMPACT." OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT VIA SEPARATE PUMP MODULES WERE VANCOMYCIN 167ML/HR., POTASSIUM 41.7ML/HR., AND ZOSYN 25ML/HR.
IT WAS REPORTED DURING AN INFUSION THE PUMP STOPPED INFUSING AND ALLEGEDLY DID NOT ALARM. ADDITIONAL INFORMATION PROVIDED: DURING A ROUTINE INFUSION OF LEVOPHED, THE PUMP REPORTEDLY STOPPED INFUSING. THE VOLUME TO BE INFUSED (VTBI) WAS 250ML, DRUG CONCENTRATION WAS 8MG/250ML. THE INTENDED RATE WAS "TITRATE AS NEEDED (PRN)". THE PATIENT REPORTEDLY BECAME HYPOTENSIVE WITH A BLOOD PRESSURE OF 68/32. THE CLINICIAN REPORTEDLY OBTAINED A NEW MODULE, TITRATED THE LEVOPHED, WHICH RAISED THE BLOOD PRESSURE. THE CUSTOMER STATED THE PATIENT "FULLY RECOVERED, NO LASTING IMPACT." OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT VIA SEPARATE PUMP MODULES WERE VANCOMYCIN 167ML/HR., POTASSIUM 41.7ML/HR., AND ZOSYN 25ML/HR. BD RECEIVED ADDITIONAL INFORMATION. AFTER THE EVENT WAS REPORTED TO BD, BD REPRESENTATIVES CAME ON SITE FOR FURTHER GATHERING OF INFORMATION. IT WAS REPORTED BY THE FACILITY'S CLINICAL ENGINEERING THAT THE CLINICIAN HAD REPORTED "THE SYSTEM FROZE UP, LOST COMMUNICATION WITH NO ALARM". DURING THE EVENT, THE CLINICIAN WAS STANDING BY THE PATIENT, AS A SECONDARY ANTIBIOTIC HAD JUST FINISHED, SAW THAT THE LEVOPHED INFUSION HAD STOPPED RUNNING. IT WAS REPORTED THAT "AFTER REPORTING THE EVENT AND BIOMED WENT TO PICK UP THE DEVICES, UNPLUGGED THE SYSTEM TO MOVE THE DEVICES, THE DEVICE ALARMED AND DISPLAYED CHANNELS A, B, C, C, AND THE DEVICES APPEARED TO RECONNECT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 997037 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention | 8015.| 8100 (3).| 8100 (4). |