ALARIS SYSTEM PC UNIT
Report
- Report Number
- 2016493-2020-73923
- Event Type
- Malfunction
- Date Received
- December 30, 2020
- Date of Event
- August 18, 2020
- Report Date
- August 19, 2020
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403801518
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
THE REPORTED SUSPECTED OVER INFUSION OF A BOLUS DOSE FOUND RECORDED AT BEING 0.05 WAS NOT CONFIRMED IN THE RECEIVED EVENT LOG AS REPORTED, IT WAS IDENTIFIED TO HAVE BEEN MANUALLY PROGRAMMED TO BE 0.5 MCG/KG FOR THE DURATION OF FIVE MINUTES AND COMPLETED AS PROGRAMMED. THE EVENT LOG HAD NO RECORDED DATA FOR THE REPORTED INCIDENT DATE OF (B)(6) 2020; THE BEGINNING LOG DATE WAS (B)(6) 2020. THE SUSPECTED OVER INFUSION OF A BOLUS DOSE IS BEING ATTRIBUTED TO PROGRAMMING AND IS NOT BELIEVED TO BE ASSOCIATED WITH A DEVICE MALFUNCTION. THE RECEIVED ASSOCIATED PCU EVENT LOG RECORDED ON THE DATE 08/19/2020, AT 04:12AM, THAT A BOLUS DOSE OF THE DRUG DEXMEDETOMIDINE, 400MCG/100ML, (DRUGID=262) WAS MANUALLY PROGRAMMED WITH A DOSE AT 0.5 MCG/KG WITH THE DURATION AT 5 MINUTES WHICH WAS THE DEFAULT. THE BOLUS DOSE COMPLETED AS PROGRAMMED INFUSING THE BOLUS VTBI OF 12.8125ML. THE PRIMARY INFUSION WAS STARTED A FEW SECONDS EARLIER THAN THE BOLUS DOSE WITH THE DOSE AT 0.1 MCG/KG/H (RATE=2.5625ML/H / DISPLAY= 2.6ML/H). THE DOSING HAD BEEN TITRATED FIVE TIMES BETWEEN 04:18AM AND 04:35AM AT VALUES OF 0.3 MCG/KG/H, 0.1 MCG/KG/H, 0.2 MCG/KG/H, 0.5 MCG/KG/H, AND 0.6 MCG/KG/H RESPECTIVELY. THE INFUSION WAS TERMINATED AT 04:44 WITH A TOTAL VOLUME INFUSED RECORDED AT PVI= 18.339ML. DEVICE HISTORY REVIEW: REVIEW OF THE SN (B)(6) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF (B)(6) 2019. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 11/11/2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY RETURNED FOR SERVICE. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE.
E1 HAS BEEN UPDATED. NEW FACILITY AND ADDRESS.
CREATED DUE TO CORRECTION TO B5 REQUESTED BY REVIEWER.
IT WAS REPORTED THAT THE INFUSION PUMP IN THE MEDICAL INTENSIVE CARE UNIT OVER-INFUSED A BOLUS OF MEDICATION. THE HEALTHCARE PROVIDER SET THE PUMP TO INFUSE AT A RATE OF 0.01 OVER ONE MINUTE, BUT STATED THE DEVICE LOG SHOWS THE MEDICATION WAS SET TO INFUSE AT A RATE OF 0.05 OVER FIVE MINUTES. THE HEALTHCARE PROVIDER WAS UNSURE IF THE ERROR WAS RELATED TO THE DEVICE OR USER PROGRAMMING AND REQUESTED REVIEW OF THE LOGS TO DETERMINE THE CAUSE OF THE OVER-INFUSION. ALTHOUGH DETAILS WERE REQUESTED, THE PATIENT IMPACT IS UNKNOWN.
IT WAS REPORTED THAT THE INFUSION PUMP IN THE MEDICAL INTENSIVE CARE UNIT OVER-INFUSED A BOLUS OF MEDICATION. THE HEALTHCARE PROVIDER SET THE PUMP TO INFUSE AT A RATE OF 0.01 OVER ONE MINUTE, BUT STATED THE DEVICE LOG SHOWS THE MEDICATION WAS SET TO INFUSE AT A RATE OF 0.05 OVER FIVE MINUTES. THE HEALTHCARE PROVIDER WAS UNSURE IF THE ERROR WAS RELATED TO THE DEVICE OR USER PROGRAMMING AND REQUESTED REVIEW OF THE LOGS TO DETERMINE THE CAUSE OF THE OVER-INFUSION. ALTHOUGH DETAILS WERE REQUESTED, THE PATIENT IMPACT IS UNKNOWN.
IT WAS REPORTED THAT THE INFUSION PUMP IN THE MEDICAL INTENSIVE CARE UNIT OVER-INFUSED A BOLUS OF MEDICATION. THE HEALTHCARE PROVIDER SET THE PUMP TO INFUSE AT A RATE OF 0.01 OVER ONE MINUTE, BUT STATED THE DEVICE LOG SHOWS THE MEDICATION WAS SET TO INFUSE AT A RATE OF 0.05 OVER FIVE MINUTES. THE HEALTHCARE PROVIDER WAS UNSURE IF THE ERROR WAS RELATED TO THE DEVICE OR USER PROGRAMMING AND REQUESTED REVIEW OF THE LOGS TO DETERMINE THE CAUSE OF THE OVER-INFUSION. ALTHOUGH DETAILS WERE REQUESTED, THE PATIENT IMPACT IS UNKNOWN.
INVESTIGATION CONCLUSION: THE REPORTED SUSPECTED OVER INFUSION OF A BOLUS DOSE FOUND RECORDED AT BEING 0.5 WAS CONFIRMED IN THE RECEIVED EVENT LOG AND WAS IDENTIFIED TO HAVE BEEN MANUALLY PROGRAMMED TO BE 0.5 MCG/KG FOR THE DURATION OF FIVE MINUTES AND COMPLETED AS PROGRAMMED. NO DEVICES WERE RETURNED FOR INVESTIGATION; HOWEVER A DEVICE MALFUNCTION IS NOT BELIEVED TO HAVE OCCURRED. THE RECEIVED ASSOCIATED PCU EVENT LOG RECORDED ON THE DATE 08/19/2020, AT 04:12AM, THAT A BOLUS DOSE OF THE DRUG DEXMEDETOMIDINE, 400MCG/100ML, (DRUGID=262) WAS MANUALLY PROGRAMMED WITH A DOSE AT 0.5 MCG/KG WITH THE DURATION AT 5 MINUTES WHICH WAS THE DEFAULT. THE BOLUS DOSE COMPLETED AS PROGRAMMED INFUSING THE BOLUS VTBI OF 12.8125ML. THE PRIMARY INFUSION WAS STARTED A FEW SECONDS EARLIER THAN THE BOLUS DOSE WITH THE DOSE AT 0.1 MCG/KG/H (RATE=2.5625ML/H / DISPLAY= 2.6ML/H). THE DOSING HAD BEEN TITRATED FIVE TIMES BETWEEN 04:18AM AND 04:35AM AT VALUES OF 0.3 MCG/KG/H, 0.1 MCG/KG/H, 0.2 MCG/KG/H, 0.5 MCG/KG/H, AND 0.6 MCG/KG/H RESPECTIVELY. THE INFUSION WAS TERMINATED AT 04:44 WITH A TOTAL VOLUME INFUSED RECORDED AT PVI= 18.339ML. DEVICE INSPECTION: N/A, NO DEVICES WERE PROVIDED FOR INVESTIGATION. ROOT CAUSE ANALYSIS: THE SUSPECTED OVER INFUSION OF A BOLUS DOSE IS BEING ATTRIBUTED TO PROGRAMMING AND IS NOT BELIEVED TO BE ASSOCIATED WITH A DEVICE MALFUNCTION. DEVICE HISTORY REVIEW: REVIEW OF THE SN (B)(4) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 11JUL2019. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 11NOV2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY RETURNED FOR SERVICE. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE. NO DEVICE RECEIVED-LOG REVIEW ONLY.
IT WAS REPORTED THAT THE INFUSION PUMP IN THE MEDICAL INTENSIVE CARE UNIT OVERINFUSED A BOLUS OF MEDICATION. THE PATIENT IMPACT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1560662 | ALARIS SYSTEM PC UNIT | PUMP, INFUSION | FRN | CAREFUSION SD | 8015 | 10885403801518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | (2)PRI TUBING,8100, TD (B)(6) 2020. |