MAUDE Adverse Event Report: CAREFUSION SD ALARIS ETCO2; PUMP, INFUSION

Model Number 8300

Device Problems Device Alarm System (1012); Pumping Stopped (1503); Device Sensing Problem (2917); Insufficient Information (3190)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

Received a copy of the customer's sus voluntary event report from fda which states, ¿we contacted a bd alaris representative concerning (19) of our etc02 infusion pump channels.We sent them a list of the devices that all seemingly fell into a recall status category, due to the error codes produced by the individual devices (fda class ii recall #2-2935-2020).The error codes (570.6200 or 570.6500) all indicate the same faulty circuit board (oridion board) and, due to the design of the channel, replacing this board is the only way to remedy the triggered errors.The bd rep sent me a response indicating that none of the serial numbers of the devices we sent him fall into the group of devices "impacted by the recall " this seems like a strange coincidence that we now have (21) pump channels (and counting) that show the same error codes expressed in the recall but are not identified in the lot of devices that the recall outlines (with specific manufacturing/distribution date ranges).We contacted a bd alaris representative concerning (19) of our etc02 infusion pump channels.We sent them a list of the devices that all seemingly fell into a recall status category, due to the error codes produced by the individual devices (fda class ii recall #2-2935-2020).The error codes (570.6200 or 570.6500) all indicate the same faulty circuit board (oridion board) and, due to the design of the channel, replacing this board is the only way to remedy the triggered errors.The bd rep sent me a response indicating that none of the serial numbers of the devices we sent him fall into the group of devices "impacted by the recall " this seems like a strange coincidence that we now have (21) pump channels (and counting) that show the same error codes expressed in the recall but are not identified in the lot of devices that the recall outlines (with specific manufacturing/distribution date ranges).The list cost of this oridion board as quoted by bd to us back in (b)(6) of this year is (b)(6) (board only, with no additional hardware for install or calculated labor).This is slightly lower than the price of a third-party company fixing it for (b)(6).So, we have a significant number of broken channels that bd is assuming no responsibility for, like other issues which have arisen.One of our pharmacists also reached out to bd the week of (b)(6) 2021 and was told the same thing our current broken serial numbers do not fall within the affected serial number range for the recall.We are seeking the fda's help in pressing bd to expand the scope of this recall, as it is very evident to us that they have a bigger problem than initially identified.Not only is this potentially a significant cost outlay for our hospital but seriously impacts our ability to provide adequate patient care with many broken infusion pumps during extremely high census days, which we are experiencing during this pandemic.Fda safety report id # (b)(4)".

Event Description

Received a copy of the customer's sus voluntary event report from fda (mw5098752) which states, ¿we contacted a bd alaris representative concerning (19) of our etc02 infusion pump channels.We sent them a list of the devices that allseemingly fell into a recall status category, due to the error codes produced by the individual devices (fda class ii recall #2-2935-2020).The errorcodes (570.6200 or 570.6500) all indicate the same faulty circuit board (oridion board) and, due to the design of the channel, replacing this board is the only way to remedy the triggered errors.The bd rep sent me a response indicating that none of the serial numbers of the devices we sent him fall into the group of devices "impacted by the recall " this seems like a strange coincidence that we now have (21) pump channels (and counting) that show the same error codes expressed in the recall but are not identified in the lot of devices that the recall outlines (with specific manufacturing/distribution date ranges).The list cost of this oridion board as quoted by bd to us back in (b)(6) of this year is (b)(6) (board only, with no additional hardware for install or calculated labor).This is slightly lower than the price of a third-party company fixing it for (b)(6).So, we have a significant number of broken channels that bd is assuming no responsibility for, like other issues which have arisen.One of our pharmacists also reached out to bd the week of (b)(6) 2021 and was told the same thing our current broken serial numbers do not fall within the affected serial number range for the recall.We are seeking the fda's help in pressing bd to expand the scope of this recall, as it is very evident to us that they have a bigger problem than initially identified.Not only is this potentially a significant cost outlay for our hospital but seriously impacts our ability to provide adequate patient care with many broken infusion pumps during extremely high census days, which we are experiencing during this pandemic.Fda safety report id #(b)(4)".

Manufacturer Narrative

The reported event of device had etco2 error, was created to document the event that the customer reported.The customer did not return the device for evaluation.No device history search was performed since no source device serial number was reported by the customer.A review of the (b)(6) 2021 complaint review board (crb) did not find an increasing trend for the reported issue of ¿etco2 error code 570.6200 or 570.6500" based on the crb review and the limited information provided no further investigation actions will be performed.Root cause analysis: the device was not returned for investigation or repair.No failure data exists to review.Therefore, the proximate cause of the customer¿s reported issue cannot be determined.The reported issue that the etco2 module error code, could not be confirmed; no product or device logs were returned for investigation.No further investigation of this event is possible at this time.The device is used for treatment purposes.H3 other text : device was not returned to manufacturing facility.

• Brand Name: ALARIS ETCO2
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11325140
• MDR Text Key: 271664840
• Report Number: 2016493-2021-25612
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• PMA/PMN Number: K031741
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1