ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-43469
- Event Type
- Malfunction
- Date Received
- November 29, 2024
- Date of Event
- October 7, 2024
- Report Date
- January 29, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OMIT: CONCOMITANT MED PROD DATA (8015), B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER? IMDRF ANNEX A, G, B, C, D CODES AND MANUFACTURER NARRATIVE. 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 REPORT OF THE DEVICE OVER-INFUSING OBINUTUZUMAB WAS ATTRIBUTED TO A USER ERROR. REVIEW OF THE DEVICE LOGS SHOW THAT THE USER CHANGED THE RATE FROM 58 ML/H TO 261 ML /H AND VTBI FROM 29 ML TO 261 ML. THE NOT ALARMING AIR IN LINE CORRECTLY COULD NOT BE DETERMINED. LABORATORY TESTING FOUND NO ISSUES WITH THE RETURNED DEVICE. A REVIEW OF THE PCU EVENT LOGS SHOWED THAT ON 07OCT2024 AT 12:44:47 PM THE PCU WAS POWERED ON, THE SUSPECT PUMP MODULE WAS ALREADY ATTACHED AND WAS ASSIGNED THE CHANNEL ¿A¿. AT 12:47:47 PM A REMOTE INTRAVENOUS (IV) MESSAGE WAS RECEIVED WITH THE FOLLOWING INFUSION PARAMETERS: DOSE=1000 MG; VOLUME TO BE INFUSED (VTBI) =290 ML; DURATION IN SECONDS=18000 (30 MINUTES); DRUG=OBINUTUZUMAB (DRUG ID: (B)(4); RATE=58 ML (THE PCU ALARMED SOFT GUARDRAILS DIALOG FOR A RATE UNDER THE RECOMMENDED LOWER RATE LIMIT. THIS IS AN INCIDENTAL FINDING AND IS NOT RELATED TO THE REPORTED COMPLAINT). AT 12:48:09 PM THE USER UPDATED THE VTBI TO 29 ML. AT 1:18:18 PM THE PUMP MODULE FINISHED THE INFUSION WITH NO MALFUNCTIONS IDENTIFIED. PRIMARY VOLUME INFUSED (PVI)=29.374 ML. AT 1:18:20 PM THE USER UPDATED THE RATE AND VTBI TO 261 ML/H AND 261 ML RESPECTIVELY (THE PCU ALARMED SOFT GUARDRAILS DIALOG FOR A RATE OVER THE RECOMMENDED UPPER RATE LIMIT, SOFT UPPER LIMIT=116.779 ML/H (THIS IS ASSOCIATED TO THE REPORTED COMPLAINT). AT 2:08:03 PM THE PUMP MODULE ALARMED PARTIAL PATIENT SIDE OCCLUSION, THE USER RESTARTED THE UNIT AND UPDATED THE VTBI TO 100 ML. PVI=238.387 ML. AT 2:26:06 PM THE USER CHANNELED OFF THE UNIT. PVI WAS RECORDED AS 317.141 ML. A REVIEW OF THE SUSPECT PUMP MODULE AND SUSPECT PCU ERROR LOGS SHOWED NO MALFUNCTIONS RELATED TO REPORTED COMPLAINT. RESULTS FROM A TIMED RATE ACCURACY AND UNREGULATED FLOW TESTING DEMONSTRATED THE DEVICE TO BE DELIVERING FLUID WITHIN SPECIFICATION. RESULTS FROM THE AIR IN LINE THRESHOLD TEST METHOD SHOWED THAT THE DEVICE ALARMED AIR IN LINE CORRECTLY. INTERNAL AND EXTERNAL INSPECTION OF THE PUMP MODULE FOUND NO IRREGULARITIES. INSPECTION AND TESTING OF THE INCIDENT ALARIS PUMP ADMINISTRATION SET COULD NOT BE PERFORMED SINCE IT WAS NOT RETURNED FOR INVESTIGATION. IT IS NOT POSSIBLE TO DETERMINE WHAT THE ACTUAL VOLUME IS WITHIN AN IV CONTAINER AT THE START AND ENDING OF AN INFUSION FROM A REVIEW OF A PUMP MODULE OR A PCU EVENT LOG. THIS IS NOT A FUNCTION OF THE EVENT LOG; IT ONLY CAN REFLECT THE INPUTTED INFORMATION IT RECEIVES EITHER MANUALLY OR REMOTELY WITH RESPECT TO VOLUME TO BE DELIVERED. THE ALARIS SYSTEM MANUAL (V12.1) STATES THAT PROPER OPERATION OF THE BD ALARIS¿ SYSTEM REQUIRES THAT YOU ARE FAMILIAR WITH RELATED FEATURES, SETUP, PROGRAMMING, IV SETS, AND ACCESSORIES. READ ALL INSTRUCTIONS, INCLUDING THOSE FOR ALL ATTACHED MODULE(S) AND ASSOCIATED DISPOSABLES BEFORE USING THE BD ALARIS¿ SYSTEM. IT IS ALSO STATED THAT ¿TO PREVENT A POTENTIAL FREE-FLOW CONDITION, ENSURE THAT NO EXTRANEOUS OBJECT (FOR EXAMPLE, BEDDING, TUBING, GLOVE) IS ENCLOSED OR CAUGHT IN THE PUMP MODULE DOOR.¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTES TO REPAIR CENTER: SUSPECT PUMP MODULE S/N: (B)(6) (WO: (B)(4). DEVICE OPENED FOR INVESTIGATION. PLEASE RE-TORQUE ALL SCREWS. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT COVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR PHYSICALLY ABUSED COMPONENTS. SUSPECT POINT OF CARE UNIT MODULE S/N: (B)(6) (WO: (B)(4). THE DEVICE REFERENCED IN THIS FILE WAS ASSOCIATED WITH OTHER DEVICES THAT WERE THE SOURCE OF THE COMPLAINT. REFERENCE THE SOURCE DEVICE FILES (B)(4) FOR CONCLUSION. THIS FILE CAN BE CLOSED BASED ON THIS FACT. NO FURTHER INVESTIGATION OF THIS DEVICE IS NECESSARY. DCHU WILL NOT COVER ANY COSTS ASSOCIATED WITH THIS DEVICE. ROOT CAUSE: THE ROOT CAUSE OF THE REPORT OF THE DEVICE OVER-INFUSING OBINUTUZUMAB WAS ATTRIBUTED TO A USER ERROR. REVIEW OF THE DEVICE LOGS SHOW THAT AFTER COMPLETION OF THE INITIAL REMOTE IV INFUSION, A MANUAL INPUT CHANGED THE RATE FROM 58 ML/H TO 261 ML /H AND VTBI FROM 29 ML TO 261 ML. THE ROOT CAUSE OF THE DEVICE NOT ALARMING AIR IN LINE CORRECTLY COULD NOT BE DETERMINED. THE DEVICE WAS THOROUGHLY TESTED AND WAS FOUND TO BE WITHIN SPECIFICATION, AND NO FAULT WAS FOUND TO BE ATTRIBUTING TO THE REPORTED INCIDENT. NOTE THAT IMDRF ANNEX A1801, C0601, D15 AND G04037 CODES NOT ASSOCIATED WITH THE ROOT CAUSE 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.
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.
IT WAS REPORTED AN OVER INFUSION OF OBINUTUZUMAB. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ADDITIONAL INFORMATION PROVIDED: "WHEN COMPLETING AN INFUSION OF OBINUTUZUMAB THE CLINICIAN NOTICED THE PRIMARY LINE ABOVE THE PUMP WAS DRY. THE PUMP WAS NOT INDICATING "AIR IN LINE" OR COMPLETION OF INFUSION. THE CLINICIAN TURNED OFF PUMP AND DISCHARGED PATIENT. WHEN DISASSEMBLING THE OBINUTUZUMAB LINE THE CLINICIAN NOTICED THAT THE MAJORITY OF THE LINE BELOW THE DEVICE WAS DRY. NO AIR HAD REACHED THE PATIENT. THE PUMP WAS SEQUESTERED AND LABELED SO THAT IT WOULD NOT BE USED."
IT WAS REPORTED AN OVER INFUSION OF OBINUTUZUMAB. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ADDITIONAL INFORMATION PROVIDED: "WHEN COMPLETING AN INFUSION OF OBINUTUZUMAB THE CLINICIAN NOTICED THE PRIMARY LINE ABOVE THE PUMP WAS DRY. THE PUMP WAS NOT INDICATING "AIR IN LINE" OR COMPLETION OF INFUSION. THE CLINICIAN TURNED OFF PUMP AND DISCHARGED PATIENT. WHEN DISASSEMBLING THE OBINUTUZUMAB LINE THE CLINICIAN NOTICED THAT THE MAJORITY OF THE LINE BELOW THE DEVICE WAS DRY. NO AIR HAD REACHED THE PATIENT. THE PUMP WAS SEQUESTERED AND LABELED SO THAT IT WOULD NOT BE USED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2618844 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |