MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Sedation (2368)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Mediastinoscopy with multiple lymph node biopsies.History of night sweats, weight loss, poor appetite, chest discomfort & lymphadenopathy.No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the patient was in the cardiovascular operating room for mediastinoscopy.Patient received induction therapy at 07:28 am and was intubated at 07:34 am.The procedure was started at 08:06 am.Dexmedetomidine was ordered for sedation at 08:03 am and a dexmedetomidine 400 mcg in 100 ml of 0.9% sodium chloride sent from the pharmacy.The dexmedetomidine started for sedation at 08:33 at a rate 0.5 mcg/kg/hr then rate was increased to 1 mcg/kg/hr.The rate of medication programming was as follows: 0.5mcg/kg/hr which is equal to 9.52ml/hr; vtbi unknown; primary.The rate on the pump was verified by a physician.The pump infused the whole dexmedetomidine.The event caused prolonged sedation, which then required pro-longed monitoring.The event prolonged the extubation of the patient.The patient received more iv medication than they would have had the event not occurred.The patient did not need a higher level of care.

Manufacturer Narrative

Additional information added to: d1.0, d.11 & h.4.Section a.1 requested however not provided.The customer¿s report that the pump infused the whole dexmedetomidine and that it caused prolonged sedation to the patient could not be confirmed or duplicate during the investigation.The testing and inspection of the pump module found no existing malfunctions and the pump module to be infusing within specification.Log analysis results: an infusion of the drug dexmedetomidine, 400mcg/100ml (drugid=443) was started with the system in anesthesia mode on (b)(6) 2020 at 8:33am.The dose was increased to 1 mcg/kg/h at 8:44am which increased the rate from 9.525ml/h to 19.05ml/h.The recorded volume infused was at 2.579ml when the infusion was interrupted by placing it in a pause state.Approximately 2 minutes later an attempt to restart was made the pump module alarmed with ¿check iv set¿.The pump module was turned off shutting down the system.The cause for the early termination and the ¿check iv set¿ alarm could not be ascertained from the log.A root cause could not be identified during the investigation.

Event Description

It was reported that the patient was in the cardiovascular operating room for a mediastinoscopy.The patient received induction therapy and was intubated at 07:28 am, and the procedure was started at 08:06 am.Dexmedetomidine was ordered for sedation and a dexmedetomidine 400 mcg in 100 ml of 0.9% sodium chloride was sent from the pharmacy.The dexmedetomidine was started for sedation at 08:33 at a rate 0.5 mcg/kg/hr; then the rate was increased to 1 mcg/kg/hr.The programming of medication was as follows: 0.5mcg/kg/hr which is equal to 9.52ml/hr; vtbi unknown; primary infusion.The programming was verified by a physician, however the entire bag infused, and the patient received more dexmedetomidine than was intended.The event caused prolonged sedation, which then required pro-longed monitoring and extended the extubation of the patient.The patient did not need a higher level of care.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9640636
• MDR Text Key: 189571775
• Report Number: 2016493-2020-00159
• Device Sequence Number: 1
• Product Code: FRN
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (3) 8100.; PRI TUBING,8015, THERAPY DATE (B)(6) 2020.
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 76