ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-24322
- Event Type
- Injury
- Date Received
- April 22, 2024
- Date of Event
- February 25, 2024
- Report Date
- September 19, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION 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. H3 OTHER TEXT : NO DEVICES RECEIVED, LOG REVIEW ONLY.
OMIT: B15 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER? AND IMDRF ANNEX B CODE. INVESTIGATION SUMMARY: THE REPORTED ISSUE OF AN OVER INFUSION OF DEXTROSE WAS NOT ABLE TO BE CONFIRMED WITH THE LOG REVIEW OR DURING THE DEVICE TESTING. THE LOG REVIEW IDENTIFIED A BASIC INFUSION OF AN UNKNOWN FLUID WAS INFUSED TO COMPLETION TWICE ON THE DATE 25FEB2024 BETWEEN THE TIME OF 2:56 AM AND 4:56 AM ON THE SUSPECT PUMP MODULE S/N: (B)(6). THE INFUSION RATE WAS AT 5.9ML/H WITH THE VOLUME TO BE INFUSED (VTBI) AT 5.9ML. THE ACCUMULATED TOTAL VOLUME INFUSED AFTER BOTH COMPLETED INFUSIONS WAS RECORDED AT 11.817ML. A THIRD BASIC INFUSION WAS STARTED AT 4:56 AM AFTER RESTORING THE ABOVE INFUSION PARAMETERS. THE THIRD BASIC INFUSION WAS ACCESSED AT THE TIME OF 5:16 AM WITH A NEW VTBI OF 5.9ML ENTERED AND THE INFUSION STARTED. THE INFUSION ALARMED FOR OCCLUDED PATIENT SIDE. THE INFUSION WAS MANUALLY TURNED OFF AT THE SAME TIME STAMP, SHUTTING DOWN THE SYSTEM, WITH THE TOTAL ACCUMULATED PVI RECORDED AT 13.712ML. 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 PCU EVENT LOG COULD NOT DETERMINE WHY THE THIRD BASIC INFUSION THAT WAS PROGRAMMED TO INFUSE FOR APPROXIMATELY 1 HOUR WAS TERMINATED EARLY AFTER ONLY INFUSING FOR APPROXIMATELY 20 MINUTES. PER PRODUCT LABELING, ALARIS SYSTEM USER MANUAL (V12.1), STATES WITHIN WARNINGS AND CAUTIONS, ¿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.¿ IT IS NOT KNOWN IF ANY OF THE PRECEDING CONDITIONS MAY HAVE EXISTED AT THE TIME OF THE REPORTED INCIDENT, AND THERE WAS NO REPORT OF AN INFUSION DISCREPANCY OCCURRING WITH THE TWO PRIOR BASIC INFUSIONS THAT INFUSED TO COMPLETION. THE ALARIS SYSTEM USER MANUAL, DOOR KEYPAD ARTWORK, AND THE QUICK REFERENCE GUIDE REMIND THE USER TO ¿CLOSE THE ROLLER CLAMP BEFORE OPENING THE DOOR¿. THE ADMINISTRATION SETS ROLLER CLAMP SHOULD BE THE PRIMARY MEANS OF CONTROLLING FLUID FLOW WHEN THE DEVICE DOOR IS OPENED. THE INSPECTION AND TESTING PROCESS DID NOT FIND ANY EXISTING MALFUNCTIONS. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATIONS WITH NO OBSERVANCES OF UNREGULATED FLOW OCCURRING. THE ADMINISTRATION SET WAS REQUESTED BUT WAS NOT RETURNED; THEREFORE, IT COULD NOT BE INSPECTED OR TESTED. ROOT CAUSE: A ROOT CAUSE FOR THE REPORTED ISSUE OF AN OVER INFUSION OF DEXTROSE WAS NOT ABLE TO BE IDENTIFIED FROM A REVIEW OF THE LOGS OR DURING DEVICE TESTING. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATIONS.
OMIT : C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. 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.
CORRECTION: DESCRIBE EVENT OR PROBLEM, UNIQUE DEVICE IDENTIFIER (UDI)#. ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿INFANT BORN TO A 35 YO (YEAR-OLD), G2P1 (GRAVIDA 2, PARA 1). 37.2 GA (37.2 WEEKS GESTATIONAL AGE). GBR NEGATIVE. C/S (CAESAREAN) DELIVERY. APGARS 8/9. BIRTH WT (WEIGHT): 2377G. AT 2 HOURS OF AGE, ADMITTED DUE TO RESPIRATORY DISTRESS. AT 0052, INITIAL BLOOD GLUCOSE 35. AT 0057, 1.5ML ORAL GLUCOSE GEL GIVEN. AT 0100, 7ML SIMILAC BOTTLE FED, AND REPEAT AT 0220 BLOOD GLUCOSE 61. RECHECKED APPROPRIATELY PER PROTOCOL. AT 0225, TFL 60ML/KG/D WITH D10 IVF (DEXTROSE 10% SOLUTION, INTRAVENOUS FLUIDS). ADVANCE FEEDS BY 15ML/KG Q (EVERY) SHIFT TO GOAL OF 160ML/KG/D AND TITRATE IVF. SEPSIS WORK UP COMPLETED UPON ADMISSION TO NICU (NEONATAL INTENSIVE CARE UNIT). AT 0225, D10 INITIATED AT 5.9ML/HR. AT 0515, GLUCOSE >600. D10 STOPPED AT THIS TIME. MD (PHYSICIAN) IMMEDIATELY NOTIFIED. THAT 250ML OF D10 WAS INFUSED. ORDERS RECEIVED TO RECHECK BLOOD GLUCOSE IN 1 HOUR. AT 0530, INSULIN ORDERED AND ORDER FOR RECHECK 30 MINUTES AFTER ADMINISTERED INSULIN THEN Q 1 HOUR CHECKS. AT 0619, GLUCOSE >600, 0.02 REGULAR INSULIN GIVEN AT AUDIT REPORT SHOWS PUMP WAS PROGRAMED AT 5.9 ML/HR WITH VTBI (VOLUME TO BE INFUSED) 5.9ML. TOTAL VOLUME PER PUMP THAT WAS INFUSED WAS 13.7ML, HOWEVER ENTIRE BAG OF 250ML HAD BEEN TRANSFUSED. TERM INFANT, ADMITTED TO NICU FOR RESPIRATORY DISTRESS AND HYPOGLYCEMIA." BD HAS LEARNED ADDITIONAL INFORMATION THROUGH CUSTOMER FOLLOW-UPS. IT WAS REPORTED THAT 244ML WAS IN FUSED IN ONE (1) HOUR AND NO OTHER MEDICATIONS WERE BEING RUN AT THE TIME OF THE EVENT.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿INFANT BORN TO A 35 YO (YEAR-OLD), G2P1 (GRAVIDA 2, PARA 1). 37.2 GA (37.2 WEEKS GESTATIONAL AGE). GBR NEGATIVE. C/S (CAESAREAN) DELIVERY. APGARS 8/9. BIRTH WT (WEIGHT): 2377G. AT 2 HOURS OF AGE, ADMITTED DUE TO RESPIRATORY DISTRESS. AT 0052, INITIAL BLOOD GLUCOSE 35. AT 0057, 1.5ML ORAL GLUCOSE GEL GIVEN. AT 0100, 7ML SIMILAC BOTTLE FED, AND REPEAT AT 0220 BLOOD GLUCOSE 61. RECHECKED APPROPRIATELY PER PROTOCOL. AT 0225, TFL 60ML/KG/D WITH D10 IVF (DEXTROSE 10% SOLUTION, INTRAVENOUS FLUIDS). ADVANCE FEEDS BY 15ML/KG Q (EVERY) SHIFT TO GOAL OF 160ML/KG/D AND TITRATE IVF. SEPSIS WORK UP COMPLETED UPON ADMISSION TO NICU (NEONATAL INTENSIVE CARE UNIT). AT 0225, D10 INITIATED AT 5.9ML/HR. AT 0515, GLUCOSE >600. D10 STOPPED AT THIS TIME. MD (PHYSICIAN) IMMEDIATELY NOTIFIED. THAT 250ML OF D10 WAS INFUSED. ORDERS RECEIVED TO RECHECK BLOOD GLUCOSE IN 1 HOUR. AT 0530, INSULIN ORDERED AND ORDER FOR RECHECK 30 MINUTES AFTER ADMINISTERED INSULIN THEN Q 1 HOUR CHECKS. AT 0619, GLUCOSE >600, 0.02 REGULAR INSULIN GIVEN AT AUDIT REPORT SHOWS PUMP WAS PROGRAMED AT 5.9 ML/HR WITH VTBI (VOLUME TO BE INFUSED) 5.9ML. TOTAL VOLUME PER PUMP THAT WAS INFUSED WAS 13.7ML, HOWEVER ENTIRE BAG OF 250ML HAD BEEN TRANSFUSED. TERM INFANT, ADMITTED TO NICU FOR RESPIRATORY DISTRESS AND HYPOGLYCEMIA." BD HAS LEARNED ADDITIONAL INFORMATION THROUGH CUSTOMER FOLLOW-UPS. IT WAS REPORTED THAT 244ML WAS IN FUSED IN ONE (1) HOUR AND NO OTHER MEDICATIONS WERE BEING RUN AT THE TIME OF THE EVENT.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿INFANT BORN TO A 35 YO (YEAR-OLD), G2P1 (GRAVIDA 2, PARA 1). 37.2 GA (37.2 WEEKS GESTATIONAL AGE). GBR NEGATIVE. C/S (CAESAREAN) DELIVERY. APGARS 8/9. BIRTH WT (WEIGHT): 2377G. AT 2 HOURS OF AGE, ADMITTED DUE TO RESPIRATORY DISTRESS. AT 0052, INITIAL BLOOD GLUCOSE 35. AT 0057, 1.5ML ORAL GLUCOSE GEL GIVEN. AT 0100, 7ML SIMILAC BOTTLE FED, AND REPEAT AT 0220 BLOOD GLUCOSE 61. RECHECKED APPROPRIATELY PER PROTOCOL. AT 0225, TFL 60ML/KG/D WITH D10 IVF (DEXTROSE 10% SOLUTION, INTRAVENOUS FLUIDS). ADVANCE FEEDS BY 15ML/KG Q (EVERY) SHIFT TO GOAL OF 160ML/KG/D AND TITRATE IVF. SEPSIS WORK UP COMPLETED UPON ADMISSION TO NICU (NEONATAL INTENSIVE CARE UNIT). AT 0225, D10 INITIATED AT 5.9ML/HR. AT 0515, GLUCOSE >600. D10 STOPPED AT THIS TIME. MD (PHYSICIAN) IMMEDIATELY NOTIFIED. THAT 250ML OF D10 WAS INFUSED. ORDERS RECEIVED TO RECHECK BLOOD GLUCOSE IN 1 HOUR. AT 0530, INSULIN ORDERED AND ORDER FOR RECHECK 30 MINUTES AFTER ADMINISTERED INSULIN THEN Q 1 HOUR CHECKS. AT 0619, GLUCOSE >600, 0.02 REGULAR INSULIN GIVEN AT AUDIT REPORT SHOWS PUMP WAS PROGRAMED AT 5.9 ML/HR WITH VTBI (VOLUME TO BE INFUSED) 5.9ML. TOTAL VOLUME PER PUMP THAT WAS INFUSED WAS 13.7ML, HOWEVER ENTIRE BAG OF 250ML HAD BEEN TRANSFUSED. TERM INFANT, ADMITTED TO NICU FOR RESPIRATORY DISTRESS AND HYPOGLYCEMIA." BD HAS LEARNED ADDITIONAL INFORMATION THROUGH CUSTOMER FOLLOW-UPS. IT WAS REPORTED THAT 244ML WAS IN FUSED IN ONE (1) HOUR AND NO OTHER MEDICATIONS WERE BEING RUN AT THE TIME OF THE EVENT.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, ¿INFANT BORN TO A 35 YO (YEAR-OLD), G2P1 (GRAVIDA 2, PARA 1). 37.2 GA (37.2 WEEKS GESTATIONAL AGE). GBR NEGATIVE. C/S (CAESAREAN) DELIVERY. APGARS 8/9. BIRTH WT (WEIGHT): 2377G. AT 2 HOURS OF AGE, ADMITTED DUE TO RESPIRATORY DISTRESS. AT 0052, INITIAL BLOOD GLUCOSE 35. AT 0057, 1.5ML ORAL GLUCOSE GEL GIVEN. AT 0100, 7ML SIMILAC BOTTLE FED, AND REPEAT AT 0220 BLOOD GLUCOSE 61. RECHECKED APPROPRIATELY PER PROTOCOL. AT 0225, TFL 60ML/KG/D WITH D10 IVF (DEXTROSE 10% SOLUTION, INTRAVENOUS FLUIDS). ADVANCE FEEDS BY 15ML/KG Q (EVERY) SHIFT TO GOAL OF 160ML/KG/D AND TITRATE IVF. SEPSIS WORK UP COMPLETED UPON ADMISSION TO NICU (NEONATAL INTENSIVE CARE UNIT). AT 0225, D10 INITIATED AT 5.9ML/HR. AT 0515, GLUCOSE >600. D10 STOPPED AT THIS TIME. MD (PHYSICIAN) IMMEDIATELY NOTIFIED. THAT 250ML OF D10 WAS INFUSED. ORDERS RECEIVED TO RECHECK BLOOD GLUCOSE IN 1 HOUR. AT 0530, INSULIN ORDERED AND ORDER FOR RECHECK 30 MINUTES AFTER ADMINISTERED INSULIN THEN Q 1 HOUR CHECKS. AT 0619, GLUCOSE >600, 0.02 REGULAR INSULIN GIVEN AT AUDIT REPORT SHOWS PUMP WAS PROGRAMED AT 5.9 ML/HR WITH VTBI (VOLUME TO BE INFUSED) 5.9ML. TOTAL VOLUME PER PUMP THAT WAS INFUSED WAS 13.7ML, HOWEVER ENTIRE BAG OF 250ML HAD BEEN TRANSFUSED. TERM INFANT, ADMITTED TO NICU FOR RESPIRATORY DISTRESS AND HYPOGLYCEMIA." BD HAS LEARNED ADDITIONAL INFORMATION THROUGH CUSTOMER FOLLOW-UPS. IT WAS REPORTED THAT 244ML WAS IN FUSED IN ONE (1) HOUR AND NO OTHER MEDICATIONS WERE BEING RUN AT THE TIME OF THE EVENT. FURTHER ADDITIONAL INFORMATION WAS PROVIDED BY A CLINICIAN THAT CARED FOR THE PATIENT. THIS INFORMATION WAS PROVIDED TO A BD REPRESENTATIVE DURING ON ON-SITE VISIT. A 250ML BAG OF D10W WAS PRIMED BY ANOTHER CLINICIAN. THAT CLINICIAN THEN LOADED THE IV TUBING INTO THE ALARIS PUMP MODULE, AND THE ROLLER CLAMP WAS CLOSED. THE PRIMED IV TUBING WAS SET ASIDE WAITING FOR IV ACCESS TO BE ESTABLISHED ON THE BABY. THE IV SITE ACCESS WAS ESTABLISHED AT 0241. THE D10W INFUSION WAS THEN CONNECTED TO THE T-CONNECTOR AND STARTED @ 0255 WITH A RATE OF 5.9ML/HOUR AND THE PRESSURE ON THE PUMP WAS SET TO 75MMHG. NO OTHER IV FLUIDS OR MEDICATIONS WERE ORDERED. THE PUMP ALARMED OCCLUSION AND THE T-CONNECTOR WAS NOTED TO BE CLAMPED. THE CLINICIAN THEN UNCLAMPED THE T-CONNECTOR AND RESTARTED THE PUMP MODULE WITHOUT AN ISSUE. AFTER 1 HOUR OF THE INFUSION, THE PUMP ALARMED INFUSION COMPLETE. THE CLINICIAN THEN CHECKED THE IV SITE AND RESET THE RATE FOR 5.9 ML/HOUR. AT 0515, THE CLINICIAN NOTED THAT THE IV BAG WAS NEARLY EMPTY. THE D10 W INFUSION WAS STOPPED AT THAT TIME, AND THERE WAS NO FLUID NOTED TO HAVE LEAKED FROM THE BAG TO THE FLOOR OR SURROUNDING AREAS. THE PHYSICIAN WAS NOTIFIED, AND A BLOOD GLUCOSE WAS OBTAINED ON THE BABY. THE BLOOD GLUCOSE WAS >600 AND ORDERS WERE CARRIED OUT. THE ALARIS SYSTEM WAS REMOVED FROM THE BEDSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2592572 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | (B)(6). |