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

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Venipuncture (2129); Toxicity (2333); No Information (3190)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

The affected device has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Although requested, patient demographics not provided.

Event Description

It was reported the device over infused an unspecified medication.

Manufacturer Narrative

The customer¿s complaint of over infusion was not confirmed or reproduced.The customer¿s complaint of failure to alarm for air in line was not reproduced.Review of the pcu error log showed no errors were recorded on the event date.Review of the pcu event log showed, on the reported event date at 8:50 am, the suspect device was selected and restored the infusion of potassium chloride (drugid= 292) at a rate of 50 ml/hr and changed the vtbi to 65 ml.Nineteen (19) minutes later, the infusion was paused.The suspect device was channeled off and removed from the pcu.No alarms were recorded.Total volume infused= 15.905 ml.Review of the dataset showed the default air bolus limit for the critical care/ed profile was set to 250 l.O at the 250 l single air bolus setting, the worst case air bubble size (299 ¿l) that could pass through the air in line sensor without triggering an alarm could be as large as 1.67 inches in length.Inspection of the device showed no anomalies with the pumping mechanism testing showed the device was delivering iv fluids within specification.Testing performed on the source pump module¿s air detection system found the device detecting air within specification at the 250 ¿l single air bolus setting.Inspection of the suspect device found no anomalies with the ail assembly (manufacture date: august 2017).The device was being used for treatment purposes.Inspection of the event administration set showed no anomalies.Functional testing of the event administration set showed no anomalies concentricity testing of the event administration set showed the set was within specification.The root cause of the customer complaint of over infusion was not identified.The root cause of the customer¿s complaint of failure to alarm for air in line was not identified.Device history review: review of the source device (sn 15139878) service history record showed the device had a manufacture date of (09feb2018).A review of the device service history record was performed beginning from the date of manufacture to the present date (22sep2020) 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 a 100ml bag of potassium chloride 20meq was programmed to infuse 65ml at a rate of 100ml/hr.About 25 minutes into the infusion, the rn checked the patient and found that the pump module had infused the entire 100ml bag.There was no air in line alarm sounded the air in the tubing did not reach the patient.It was mentioned that the device indicated a volume of 49ml of potassium chloride still left to be infused.It was then reported that the physician was notified, the patient's blood was drawn, and ekg monitoring was performed for potassium toxicity.The devices were then taken out of service.The event occurred at cardiac care unit (ccu).

Manufacturer Narrative

Additional information added to: b5.

Event Description

It was reported that the cardiac care unit (ccu) was infusing a programmed 100ml bag of 20meq potassium with a setting volume to be infused of 65ml at a rate of 100ml per hour.About 25 minutes into the infusion the rn checked the patient and found the channel had infused the entire 100ml bag and was now infusing air.There was no air in line alarm sounded and no air reached the patient.The pump read 49ml of potassium still left in the bag to be infused and it was still running/infusing at this point.The pump #404492688 and channel #405002827 were taken out of service.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10534600
• MDR Text Key: 221018180
• Report Number: 2016493-2020-05733
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• 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,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (3)8100,(3)PRI TUBING.; 2426-0500,8015, THERAPY DATE (B)(6) 2020.
• Patient Outcome(s): Required Intervention