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

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

The report of an over infusion was not definitively identified due to specific details were not provided.Log analysis results: the pcu event log shows pump module s/n (b)(4) was programmed to infuse drugid 372 at 1:19 pm on (b)(6) 2021.The rate for drugid 372 was prepopulated to be 100ml/hr and the vtbi was prepopulated to be 100ml.At 1:26 pm, the infusion was paused and then restarted at 1:50 pm.Between 1:51 pm and 2:00 pm, the device alarmed 4 times for patient side occlusion and each time the user restarted the infusion.At 2:08 pm, the infusion was paused and then restarted at 2:09 pm.At 2:40 pm, the device alarmed for air in line and then was restarted at 2:41 pm.The device alarmed again for air line and the device was then channeled off at 2:42 pm.At 2:48 pm, the device alarmed for flo stop open for 7 seconds.At 2:49 pm, the user programmed an infusion of drugid 375.The rate for drugid 375 was prepopulated to be 200ml/hr and the vtbi was prepopulated to be 100ml.At 3:37 pm, the device alarmed for air in line.At 3:18 pm, the infusion was paused and then 3 seconds later the pump module was removed.Ten seconds later the user selected softkey 14 to address the channel disconnect pop-up.At 4:04 pm, the system was shutdown and powered off.The volume recorded as being infused during this period was 182.765ml.The root cause of the reported over infusion was not definitively identified due to specific details were not provided.A review of the device history record showed the device had a manufacture date of (b)(6) 2010.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for pcu s/n (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record in trackwise and sap was performed for the pcu s/n (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of (b)(4) 2007.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for pump module s/n (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record in trackwise and sap was performed for the pump module s/n (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.Time of event: 1445.No device received-log review only.

Event Description

It was reported that an over infusion of potassium chloride occurred due to a connection error on the 8100.The patient required minor treatment but there was no patient harm per the customer.The customer stated that their "staff has already concluded that this was user error" but is requesting the log reviews be reviewed.

Manufacturer Narrative

Additional information: d10, d11.Investigation conclusion: the report of an overinfusion was not definitively identified due to specific details were not provided.The event description stated that ¿an overinfusion of potassium chloride occurred due to a connection error on the 8100.¿ the pcu event log shows a channel disconnect occurred at 3:18 pm on (b)(6) 2021, however it is unknown if this was the connection error that the user was referring to.Furthermore, a connection error would not result in an overinfusion.The report of an overinfusion was not definitively identified due to specifics regarding the event were not provided, however the pcu event log suggests an overinfusion did possibly occur due to user programming based on the pump module was initially programmed at 1:19 pm on (b)(6) 2021 to infuse drugid 372, which had a prepopulated rate of 100ml/hr and vtbi of 100ml.The pump module was then programmed to infuse drugid 375 after the device was channeled off at 2:42 pm.Drugid 375 had a prepopulated rate of 200ml/hr and vtbi of 100ml.It appears that the different drug selection that was programmed was the cause of the overinfusion since it is twice the originally programmed rate however, since the intended rate was not specified, it cannot be definitively determined if user programming was the cause of the overinfusion.The medications in use (drugid 372 and drugid 375) were not identified due to not being provided the customer¿s dataset.Device inspection: n/a, only the device event logs were received for investigation.The incident administration set was not returned and could not be inspected.Root cause analysis: the root cause of the reported overinfusion was not definitively identified due to specific details were not provided.Device history review: a review of the device history record showed the device had a manufacture date of 18oct2007.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for pump module s/n (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the pump module s/n (b)(6)which did not confirm similar complaints with the same or related failure mode for this customer.H3 other text : no device received-log review only.

Event Description

It was reported that an overinfusion of potassium chloride occurred due to a connection error on the 8100.The patient required minor treatment but there was no patient harm per the customer.The customer stated that their "staff has already concluded that this was user error" but is requesting the log reviews be reviewed.

Event Description

It was reported that an over infusion of potassium chloride occurred due to a connection error on the 8100.The patient required minor treatment but there was no patient harm per the customer.The customer stated that their "staff has already concluded that this was user error" but is requesting the log reviews be reviewed.

• 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: 11304323
• MDR Text Key: 239206702
• Report Number: 2016493-2021-21008
• 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,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: Not provided; 01/29/2021
• Supplement Dates FDA Received: 02/24/2021; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (3)PRI_TUBING, (3)8100.; PRI TUBING,8015, THERAPY DATE (B)(6)2021.