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

Model Number 8300

Device Problems Device Alarm System (1012); Pumping Stopped (1503); Failure to Read Input Signal (1581); Device Sensing Problem (2917)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Patient is an adult.The customers complaint of two etc02 unable read the patient's exhaled carbon dioxide was attributed to error code 570.6200.Inspection: the etc02 module 15426000 was received with instrument seal intact.The device was observed in overall good condition.Internal inspection observed no signs of fluid ingress.The oridion board was observed with s/n (b)(4).Log analysis results: the pcu device was not returned for this investigation therefore no programming parameters could be determined.The etc02 s/n 15426000 was attempted to be used on (b)(6) 2020 four times from 11:57 pm to 1:18 pm each time the user was unsuccessful, each time the module error for 570.6200.Review of the etc02 error logs confirmed instances of error code 570.6200 on both received modules on the customer reported incident date of (b)(6) 2020.The returned etc02 module s/n 15426000 was functionally tested as received and did not confirm any observed errors.On 04 aug 2020 bd issued a medical device recall for the alaris¿ etco2 module model 8300 to address channel error code 570.6200 or 570.6500.The recall addresses affected product manufactured from january 5, 2018 to january 4, 2019.Internal inspection of both received etc02 modules oridion boards observed the oridion boards affected by the product recall.Supplier corrective action request was opened for this issue.Root cause: the cause of the customer complaint of the etc02 modules failed to read the patient's exhaled carbon dioxide was attributed to error code 570.6200.The root cause of the error code 570.6200 was attributed to medtronic sub-tier supplier issue.The root cause determined that medtronic¿s oridion board sub-tier supplier (usr) was using ethanol as a lubricant to install the plastic o-ring and the chemical reaction caused the o-ring to degrade over time.The degradation of the o-ring causes blockage of the filter line causing the unit to fail and present channel error code 570.6200 or 570.6500.Device history review: a review of the device history record showed the device had a manufacture date of 12/11/2018.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 15426000 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 was performed for the 15426000 which confirmed similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that during an unspecified pca (patient controlled analgesia) infusion, the etco2 (end-tidal carbon-dioxide) pump module failed to read the patient's exhaled carbon dioxide.There was no patient impact.Although requested, further information was not provided.

Manufacturer Narrative

Correction/addition: reportable malfunction per information received 09/25/2020.B5, g3 & h6 health effect - clinical code and impact code, and medical device problem codes, h7, h9.

Event Description

It was reported that during an unspecified pca (patient controlled analgesia) infusion, the etco2 (end-tidal carbon-dioxide) pump module failed to read the patient's exhaled carbon dioxide.There was no patient impact.Although requested, further information was not provided.

• 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: 11289307
• MDR Text Key: 242591644
• Report Number: 2016493-2021-23841
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: 10885403830013
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2935-2020
• Patient Sequence Number: 1
• Treatment: SYRTUBE,8120,8015,ETCO2DISP, TD (B)(6) 2020.