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

Model Number 8100

Device Problems Contamination (1120); Failure to Cycle (1142); Misassembled (1398); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced motor assembly was stuck causing channel error (b)(4).The failures leading to motor stall (error code (b)(4)) was confirmed and replicated during testing.Review of the pump module error logs confirmed motor stall error code (b)(4) (motor_stall_failure) was present in the logs.Internal inspection confirmed optical sensor (op1) was damaged on the air-in-line sensor assembly.Replacement of the air-in-line assembly and subsequent functional testing the pump module functioned properly with no further alarms or malfunctions occurring.A review of the device history record for sn (b)(4) was performed, which showed the device had a manufacture date of 11sep2018 and confirmed that this device was not involved in a production failure which correlates to the customer reported issue.The review was performed from the date of manufacture to the date of product release for distribution.A review of the complaint history record was performed for the sn (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 unknown issue with the device occurred.It needs repairs and/or service.No additional information was provided.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced motor assy was ctuck cause channel error 242.4030.Fluid ingress replaced rear case housing,sub mechanisim assy.Lvp keypad recall completed.The failure code othe was used to track the alaris 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 11sep2018.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 sn (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 cause of the reported issue was due to mechanical failure of the assy motor w/ harn 8100.During servicing we identified a motor stall which constitutes a reportable malfunction.There was no patient involvement.The failures leading to motor stall (error code 242.4030) was confirmed and replicated during testing.Review of the pump module error logs confirmed motor stall error code 242.4030.0 (motor_stall_failure) was present in the logs.Internal inspection confirmed optical sensor (op1) was damaged on the air-in-line sensor assembly.Replacement of the air-in-line assembly and subsequent functional testing the pump module functioned properly with no further alarms or malfunctions occurring.This failure mode is being monitored through previously investigated complaint process.A review of the complaint history record in trackwise and sap 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 that an unknown issue with the device occurred.It needs repairs and/or service.No additional information was provided.There was no patient involvement.

• 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: 11820692
• MDR Text Key: 250625473
• Report Number: 2016493-2021-506141
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0950-2017
• Patient Sequence Number: 1