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

Model Number 8120

Device Problems Failure to Analyze Signal (1539); Failure to Read Input Signal (1581); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.

Event Description

It was reported by the customer that the device fails calibration.There was no additional information provided and no patient involvement.

Event Description

It was reported by the customer that the device fails calibration.There was no additional information provided and no patient involvement.

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced linear sensor.The failure code other was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 21nov2018.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 (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the probable root cause of the reported issue was due to electrical failure of the linear sensor 8110/8120.A review of the complaint history record in trackwise and sap was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported by the customer that the device fails calibration.There was no additional information provided and no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician replaced linear sensor.Based on the findings, service determined that the reported issue was due to linear sensor electrical failure.Device history record: a review of the device history record showed the device had a manufacture date of 21nov2018.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 (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 sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported by the customer that the device fails calibration.There was no additional information provided and no patient involvement.

• Brand Name: ALARIS PCA
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11389411
• MDR Text Key: 233897580
• Report Number: 2016493-2021-29171
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 10885403812002
• Combination Product (y/n): N
• PMA/PMN Number: K043299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1