MAUDE Adverse Event Report: CAREFUSION SD ALARIS PC UNIT; PUMP, INFUSION

Model Number 8015

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

The customer¿s report of medication infusing faster than programming was due to the user programming an infusion at an unintended custom concentration.¿on (b)(6) 2020 at 7:18 am and at 8:20 am the user programmed an infusion of sufentanil (drugid 463) with a 20ml syringe and a drug amount of 100mcg in diluent 100ml (instead of the intended 20 ml) with a rate of 23.4ml.At 8:50 am the user entered a dose 0.25mcg/kg/h which adjusted the rate to 19.5ml/h.¿the customer reported that the intended rate was 7.86ml/hr making the programmed rates approximately 2x and 3x over infusions.¿no errors or malfunctions were recorded in the syringe module error logs on the customers reported incident date of (b)(6) 2020.¿functional testing found the as received syringe module passing, plunger force accuracy, barrel clamp accuracy test and plunger position accuracy test.The root cause of the customers report of the medication infused faster than programmed was due to user programing (custom concentration).No device malfunction is believed to have occurred.Review of the pcu s/n (b)(4) service history record showed the device had a manufacture date of 09/16/2019.A review of the device service history record was performed beginning from the date of manufacture to the present date 10/19/2020 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.

Event Description

It was reported that the clinician mixed 100mcg sufentanil into 20ml of fluid (5mcg/ml) and programmed the syringe pump to infuse at a rate of 0.5 mcg/kg/hr = 7.86ml/hr, however the medication infused faster than programmed "after a short time." the nurse re-programmed the pump with the same concentration to infuse another 100mcg, which also infused too quickly, at which point the clinician noted the error.The patient's electronic medical record (emr) epic indicated that a total of 50mcg had been delivered to the patient, however the patient had actually received a total of 200mcg.The clinician then corrected the dosing documentation in epic to reflect the true amount administered to the patient.Due to the event, the patient required additional oxygen monitoring overnight and a prolonged pacu stay, however the patient did not require any additional medical intervention to preclude serious injury.There was no patient harm.

Manufacturer Narrative

Revised to a serious injury, aware date of (b)(6) 2020.*******************************************************************************************.

Event Description

It was reported that the clinician mixed 100mcg sufentanil into 20ml of fluid (5mcg/ml) and programmed the syringe pump to infuse at a rate of 0.5 mcg/kg/hr = 7.86ml/hr, however the medication infused faster than programmed "after a short time." the nurse re-programmed the pump with the same concentration to infuse another 100mcg, which also infused too quickly, at which point the clinician noted the error.The patient's electronic medical record (emr) epic indicated that a total of 50mcg had been delivered to the patient, however the patient had actually received a total of 200mcg.The clinician then corrected the dosing documentation in epic to reflect the true amount administered to the patient.Due to the event, the patient required additional oxygen monitoring overnight and a prolonged pacu stay, however the patient did not require any additional medical intervention to preclude serious injury.There was no patient harm.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10823445
• MDR Text Key: 227207097
• Report Number: 2016493-2020-31928
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYRTUBE, THERAPY DATE 06/12/2020
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 26 YR
• Patient Weight: 78