ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-35562
- Event Type
- Malfunction
- Date Received
- September 9, 2024
- Date of Event
- August 15, 2024
- Report Date
- October 23, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. 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: B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE REPORTED ERROR CODE MESSAGE 13-1033-149 WAS NOT CONFIRMED TO HAVE OCCURRED ON THE REPORTED INCIDENT DATE DURING THE REVIEW OF THE LOG OR WAS THE ERROR CODE EVENT REPLICATED DURING LABORATORY TESTING. THE REPORT OF THE SOFTWARE ERROR CODE 13-1033-149 WAS IDENTIFIED THROUGH LOG ANALYSIS TO HAVE OCCURRED ON THE DATE (B)(6) 2024 AT THE TIME OF 6:47 AM JUST AFTER THE SYSTEM WAS POWERED ON, NO INFUSIONS WERE ACTIVE OR PROGRAMMED AT THE TIME. THE REVIEW OF THE PUMP MODULE (SN:(B)(6)) EVENT LOG OBSERVED THE SOFTWARE ERROR CODE 13-1033-149 OCCURRED ON (B)(6) 2024, AT 6:47 AM. WHEN THE ABOVE SOFTWARE ERROR CODE OCCURRED BOTH PUMP MODULES (SN: (B)(6) AND SN: (B)(6)) WERE EXPERIENCING COMMUNICATION ERROR AND FOLLOWED WITH THEIR POWER INTERRUPTED NUMEROUS TIMES. ON THE DATE (B)(6) 2024 AT THE TIME OF 8:43 PM BOTH PUMP MODULES (SN: (B)(6) AND SN: (B)(6)) ENTERED A COMMUNICATION ERROR STATE WHILE THE MODULES WERE INFUSING AND THE PCU ALARMED ¿CHANNEL DISCONNECTED¿. THE SYSTEM WAS SHUT DOWN AT THE TIME OF 8:49 PM. INSPECTION OF THE SUSPECTED PCU (SN: (B)(6)) FOUND THE RIGHT IUI CONNECTOR IN GOOD CONDITION WITH A DATE CODE OF 07-17 (JULY 2017) AND THE LEFT IUI CONNECTER FOUND AS A THIRD-PARTY PART. THE PUMP MODULE (SN:(B)(6)) WAS ATTACHED TO THE THIRD-PARTY IUI CONNECTOR ON THE PCU AS CHANNEL ¿B¿, AND (SN: (B)(6)) WAS ATTACHED TO THE CHANNEL ¿B¿ PUMP MODULE AS CHANNEL ¿A¿. THE INSPECTION PROCESS DID NOT FIND AN ISSUE WITH THE PUMP MODULE IUI CONNECTORS THAT MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE IDENTIFIED COMMUNICATION ERRORS AND POWER INTERRUPTIONS AT THE MODULES. CHANNEL DISCONNECT TESTING WERE UNABLE TO REPLICATE THE COMMUNICATION ERROR OR SOFTWARE ERROR CODE 13-1033-149 EVENTS. BD ALARIS SYSTEM CHANNEL DISCONNECT TIP SHEET RECOMMENDS INSPECTING THE IUI CONNECTOR PRIOR TO EACH USE. IF ANY SURFACE CONTAMINANTS, CRACKS OR OTHER SIGNS OF DAMAGE ARE VISIBLE, THIS MEANS THE CONNECTOR REQUIRES REPLACEMENT. USE OF DAMAGE DEVICES WITH DAMAGE IUI CONNECTORS CAN RESULT IN PATIENT HARM. SEND ALL DAMAGED DEVICES TO BIOMEDICAL ENGINEERING FOR REPAIRS. BD ISSUED A VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION DATED JUNE 30, 2020, TO ADDRESS SPECIFIC CLEANING PRACTICES AS IT RELATES TO THE BD ALARIS SYSTEM WHICH CONTAINS THE FOLLOWING NOTIFICATIONS RELATED TO CLEANING: BEST PRACTICES FOR CLEANING BD ALARIS ¿ SYSTEM DEVICES, BD ALARIS¿ SYSTEM CLEANING AUDIT, BD ALARIS¿ SYSTEM CLEANING CHECKLIST, BD ALARIS ¿ SYSTEM IUI INSPECTION QUICK REFERENCE. BD ALARIS ¿ SYSTEM WITH GUARDRAILS ¿ SUITE MX USER MANUAL ADDENDUM JULY 2020 AS A RESULT, THE CLEANING REQUIREMENTS WERE UPDATED TO ALIGN WITH IEC 60601.1 11.6.6 STANDARDS. THE BEST PRACTICES FOR CLEANING ALARIS SYSTEM DEVICES TIP SHEET RECOMMENDS NOT ALLOWING THE CLEANER TO COLLECT ON THE INSTRUMENT AND NOT USING AN OVERSATURATED CLOTH DURING THE CLEANING PROCESS. BE SURE TO SQUEEZE OUT EXCESS LIQUID. THE INSPECTION PROCESS IDENTIFIED THE PCU LEFT IUI CONNECTOR WAS THIRD-PARTY. BD DOES NOT RECOMMEND THE USE OF THIRD-PARTY PARTS FOR THE ALARIS SYSTEM. BD HAS NOT TESTED NOR VALIDATED THE PERFORMANCE AND FUNCTIONALITY OF ITS MEDICAL DEVICES WHEN USED WITH REPLACEMENT PARTS MANUFACTURED/REFURBISHED AND SOLD BY THIRD PARTIES. BD STRONGLY RECOMMENDS NOT USING ANY THIRD PARTY COMPONENTS FOR THE MAINTENANCE, SERVICE, AND REPAIR OF BD DEVICES EXCEPT AS EXPLICITLY STATED OTHERWISE IN THE ALARIS SYSTEM USER MANUAL. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER: THE SUSPECT PCU DEVICE WAS OPENED DURING THE INVESTIGATION; PLEASE ENSURE PROPER ASSEMBLY AND TORQUE SCREWS AS REQUIRED. IT WAS NOTED THAT THE PCU LEFT IUI CONNECTOR WAS THIRD-PARTY, SUSPECTED TO BE THE CAUSE FOR THE REPORTED ISSUE. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT BE PICKING UP THE COST OF THE INCIDENTAL REPAIRS. ROOT CAUSE: THE PROBABLE CAUSE FOR THE REPORTED ISSUE OF A DEVICE ERROR 13-1033-149 DURING AN INFUSION IS BEING ATTRIBUTED TO THE USE OF AN UNAPPROVED THIRD-PARTY INTER-UNIT-INTERFACE (IUI) CONNECTOR ON THE PCU THAT AFFECTED THE PUMP MODULES ATTACHED WITH COMMUNICATION ERRORS AND POWER INTERRUPTIONS TO THE PUMP MODULES. BD HAS PERFORMED CONTINUOUS IMPROVEMENT TO THE LEFT (FEMALE) IUI CONNECTOR THAT HAS STRINGENT DESIGN REQUIREMENTS THAT WOULD NOT BE KNOWN TO A THIRD-PARTY MANUFACTURER. BD WAS NOT ABLE TO CONFIRM ANY SOFTWARE ERROR CODE 13-1033-149 HAVING OCCURRED DURING AN INFUSION BUT DID CONFIRM THE ERROR OCCURRED THE DAY AFTER THE REPORTED INCIDENT.
IT WAS REPORTED THAT THE PCU HAD ERROR CODE MESSAGE 13-1033-149 DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM. FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER WHICH STATED PC WAS ALARMING STATING "CHANNEL B ERROR 13-1033-149 AND CHANNEL A WAS ALARMING FOR COMMUNICATION ERROR". WHEN DELIVERED TO BIOMEDICAL ENGINEERING IT WAS NOTED THERE WAS "MOISTURE AND WETNESS ON THE SIDES BETWEEN THE CONNECTING PUMP BRAIN AND CHANNELS"
IT WAS REPORTED THAT THE PCU HAD ERROR CODE MESSAGE 13-1033-149 DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO HARM. FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER WHICH STATED PC WAS ALARMING STATING "CHANNEL B ERROR 13-1033-149 AND CHANNEL A WAS ALARMING FOR COMMUNICATION ERROR". WHEN DELIVERED TO BIOMEDICAL ENGINEERING IT WAS NOTED THERE WAS "MOISTURE AND WETNESS ON THE SIDES BETWEEN THE CONNECTING PUMP BRAIN AND CHANNELS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1601249 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8100(3). |