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

Model Number 8015

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 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.¿ 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 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 10aug2010.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record 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 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.

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 SYSTEM PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11346706
• MDR Text Key: 233101649
• Report Number: 2016493-2021-26602
• 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,health
• Type of Report: Initial,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: 8015
• Device Catalogue Number: 8015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (4)PRI TUBING, (2)8100, 10992182, TD ON (B)(6) 2021.