ALARIS® PUMP MODULE
Report
- Report Number
- 2016493-2019-01670
- Event Type
- Injury
- Date Received
- December 19, 2019
- Date of Event
- November 26, 2019
- Report Date
- November 27, 2019
- 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
- MN, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: A.2, A.3, A.4, B.5, D.10, H.3, H.6, PATIENT CODE ADDITIONAL PATIENT INFORMATION: ADMITTING DIAGNOSIS: ACUTE RESPIRATORY FAILURE WITH HYPOXIA; RELEVANT TESTS AND LAB DATA: HYPOTENSIVE, DAILY ANTI XA LAB WORK THE CUSTOMER¿S REPORT THAT THE PROPOFOL INFUSED FASTER THAN THE PROGRAMMED RATE OF 16.6 ML/H COULD NOT BE CONFIRMED OR REPLICATED DURING INVESTIGATION. ¿ NO CONCLUSION COULD BE DRAWN THROUGH LOG REVIEW REGARDING THE USER¿S REPORTED EXPERIENCE OF A DRUG INFUSING FASTER THAN THE PROGRAMMED RATE. O THE TOTAL VOLUME INFUSED WAS 1.559 ML. ¿ RATE ACCURACY TESTING PERFORMED FOUND THE PUMP MODULE WAS DELIVERING FLUIDS WITHIN SPECIFICATION. ¿ THE INSPECTION PROCESS PERFORMED ON THE PUMP MODULE FOUND NO IRREGULARITIES. ¿ THE DISPOSABLE SET WAS NOT RETURNED FOR THIS INVESTIGATION, THEREFORE IT IS UNKNOWN IF THE SET MAY HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. ¿ THE PUMP MODULE WAS FOUND TO BE DELIVERING FLUIDS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE EVENT WAS NOT IDENTIFIED.
ADDITIONAL PATIENT INFORMATION: ADMITTING DIAGNOSIS: ACUTE RESPIRATORY FAILURE WITH HYPOXIA; RELEVANT TESTS AND LAB DATA: HYPOTENSIVE, DAILY ANTI XA LAB WORK. THE CUSTOMER¿S REPORT THAT THE PROPOFOL INFUSED FASTER THAN THE PROGRAMMED RATE OF 16.6 ML/H COULD NOT BE CONFIRMED OR REPLICATED DURING INVESTIGATION. NO CONCLUSION COULD BE DRAWN THROUGH LOG REVIEW REGARDING THE USER¿S REPORTED EXPERIENCE OF A DRUG INFUSING FASTER THAN THE PROGRAMMED RATE. THE TOTAL VOLUME INFUSED WAS 1.559 ML. RATE ACCURACY TESTING PERFORMED FOUND THE PUMP MODULE WAS DELIVERING FLUIDS WITHIN SPECIFICATION. THE INSPECTION PROCESS PERFORMED ON THE PUMP MODULE FOUND NO IRREGULARITIES. THE DISPOSABLE SET WAS NOT RETURNED FOR THIS INVESTIGATION, THEREFORE IT IS UNKNOWN IF THE SET MAY HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. THE PUMP MODULE WAS FOUND TO BE DELIVERING FLUIDS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE EVENT WAS NOT IDENTIFIED.
IT WAS REPORTED THAT AN ICU PATIENT WAS RECEIVING NOREPINEPHRINE, PROPOFOL, HYDROMORPHONE AND HEPARIN AT THE RATES MENTIONED BELOW. THE USER NOTED VIA ARTERIAL LINE THAT THE PATIENT BLOOD PRESSURE "DROPPED RAPIDLY" WITH AN ARTERIAL PRESSURE READING IN THE 30S. THE NEWLY HUNG PROPOFOL INFUSION (50 MCG/KG/MIN) AT 16.6ML/HR. WAS NOTED TO BE INFUSING MUCH FASTER THAN THE PROGRAMMED RATE. THE RN ADMINISTERED PHENEPHRINE 200MCG IVP AND NOREPINEPHRINE WAS TITRATED TO INCREASE THE BLOOD PRESSURE. THE PROPOFOL INFUSION WAS IMMEDIATELY PAUSED AND LINE CLAMPED. THE CUSTOMER REPORTED UNSPECIFIED PATIENT HARM. THE CUSTOMER LATER STATED THAT THE INFUSIONS WERE AS FOLLOWS: PROPOFOL 50MCG/KG/MIN, START AT 10MCG/KG/MIN, TITRATE EVERY 10 MINUTES PER PROTOCOL. THE PROPOFOL INFUSION WAS FIRST PROGRAMMED ON 11/23/2019 AT 1619 ON MODULE #14561138 WITH THE DOSE PROGRAMMED AS 2MCG/KG/MIN, INFUSING AT A RATE OF 8.2ML/HOUR. FROM 11/23 TO 11/26, THE PROPOFOL WAS TITRATED BETWEEN 20 AND 50MCG/KG/MIN, WITH AN OVERALL RATE RANGE BETWEEN 8.2ML TO 24.2ML/HOUR. ON 11/26 AT 1308, THE INFUSION WAS STOPPED ON MODULE 1451137, THEN STARTED ON MODULE 14560832 WITH A DOSE OF 50MCG/KG/MIN INFUSING AT A RATE OF 16.6ML/HR. AT 1422, THE INFUSION STOPPED. THE OCCURRENCE TIME WAS DOCUMENTED AS 1351. THE NOREPINEPHRINE WAS PROGRAMMED AT 0.04MCG/KG/MIN, TITRATED TO DESIRED GOAL. THE HYDROMORPHONE INFUSION WAS PROGRAMMED AT 0.5MG/HR, GIVE 1MG IV PUSH, THEN START AT 0.5MG/HOUR, TITRATE TO DESIRED GOAL. THE HEPARIN INFUSION WAS PROGRAMMED AT AN INITIAL RATE OF 18UNITS/KG/HR. A NOTE RECEIVED WITH THE DEVICES THAT STATED: ¿70ML OF PROPOFOL WAS DELIVERED OVER 3 MINS WHEN ONLY 16 ML/HR PROGRAMMED TO DELIVER. SEE INCIDENT REPORT SI 102814". IT WAS ALSO REPORTED THAT PMS AND INSPECTIONS WERE UP-TO-DATE ON ALL UNITS.
IT WAS REPORTED THAT AN ICU PATIENT WAS RECEIVING NOREPINEPHRINE, PROPOFOL, HYDROMORPHONE AND HEPARIN AT THE RATES MENTIONED BELOW. THE USER NOTED VIA ARTERIAL LINE THAT THE PATIENT BLOOD PRESSURE "DROPPED RAPIDLY" WITH AN ARTERIAL PRESSURE READING IN THE 30S. THE NEWLY HUNG PROPOFOL INFUSION (50 MCG/KG/MIN) AT 16.6ML/HR. WAS NOTED TO BE INFUSING MUCH FASTER THAN THE PROGRAMMED RATE. THE RN ADMINISTERED PHENEPHRINE 200MCG IVP AND NOREPINEPHRINE WAS TITRATED TO INCREASE THE BLOOD PRESSURE. THE PROPOFOL INFUSION WAS IMMEDIATELY PAUSED AND LINE CLAMPED. THE CUSTOMER REPORTED UNSPECIFIED PATIENT HARM. THE CUSTOMER LATER STATED THAT THE INFUSIONS WERE AS FOLLOWS: PROPOFOL 50MCG/KG/MIN, START AT 10MCG/KG/MIN, TITRATE EVERY 10 MINUTES PER PROTOCOL. THE PROPOFOL INFUSION WAS FIRST PROGRAMMED ON 11/23/2019 AT 1619 ON MODULE #14561138 WITH THE DOSE PROGRAMMED AS 2MCG/KG/MIN, INFUSING AT A RATE OF 8.2ML/HOUR. FROM 11/23 TO 11/26, THE PROPOFOL WAS TITRATED BETWEEN 20 AND 50MCG/KG/MIN, WITH AN OVERALL RATE RANGE BETWEEN 8.2ML TO 24.2ML/HOUR. ON 11/26 AT 1308, THE INFUSION WAS STOPPED ON MODULE 1451137, THEN STARTED ON MODULE 14560832 WITH A DOSE OF 50MCG/KG/MIN INFUSING AT A RATE OF 16.6ML/HR. AT 1422, THE INFUSION STOPPED. THE OCCURRENCE TIME WAS DOCUMENTED AS 1351. THE NOREPINEPHRINE WAS PROGRAMMED AT 0.04MCG/KG/MIN, TITRATED TO DESIRED GOAL. THE HYDROMORPHONE INFUSION WAS PROGRAMMED AT 0.5MG/HR, GIVE 1MG IV PUSH, THEN START AT 0.5MG/HOUR, TITRATE TO DESIRED GOAL. THE HEPARIN INFUSION WAS PROGRAMMED AT AN INITIAL RATE OF 18UNITS/KG/HR. A NOTE RECEIVED WITH THE DEVICES THAT STATED: ¿70ML OF PROPOFOL WAS DELIVERED OVER 3 MINS WHEN ONLY 16 ML/HR PROGRAMMED TO DELIVER. SEE INCIDENT REPORT SI 102814". IT WAS ALSO REPORTED THAT PMS AND INSPECTIONS WERE UP-TO-DATE ON ALL UNITS.
CONCOMITANT MEDICAL PRODUCTS: (3)8100;8015;(4)PRI TUBING;A- LINE; IVP SYRINGE; TD (B)(6) 2019. ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION. REQUESTED PATIENT WT. AGE, DIAGNOSIS REQUESTED HOWEVER NOT PROVIDED.
IT WAS REPORTED THAT AN ICU PATIENT WAS RECEIVING NOREPINEPHRINE, PROPOFOL, HYDROMORPHONE AND HEPARIN AT UNSPECIFIED RATES. THE USER NOTED VIA ARTERIAL LINE THAT THE PATIENT BLOOD PRESSURE "DROPPED RAPIDLY" WITH AN ARTERIAL PRESSURE READING IN THE 30S. THE NEWLY HUNG PROPOFOL INFUSION (50 MCG/KG/MIN) 16.6ML/HR. WAS NOTED TO BE INFUSING MUCH FASTER THAN THE PROGRAMMED RATE. THE RN ADMINISTERED PHENEPHRINE 200MCG IVP AND NOREPINEPHRINE WAS TITRATED AT AN UNSPECIFIED RATE. THE PROPOFOL INFUSION WAS IMMEDIATELY PAUSED AND LINE CLAMPED. THE CUSTOMER REPORTED UNSPECIFIED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1294086 | ALARIS® PUMP MODULE | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Male | Required Intervention | SEE H.10 |