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

Model Number 8120

Device Problems Break (1069); Crack (1135); Deformation Due to Compressive Stress (2889); Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The affected device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the device was broken / damaged.There was no patient involvement.

Event Description

It was reported that the device was broken / damaged.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 front cover, rear case, left/ right handles, front/ rear doors, barrel clamp, lock label, latch module, tube drive, sleeve drive, wiper seal, flange gripper retainer, small/ large claws and left/ right iui's.Performed calibration.The failure code othe 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 25jan2012.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 root cause of the reported issue was due to wear of the front case - damaged/ cracked (front cover bottom left corner).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.

• Brand Name: ALARIS PCA MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11355773
• MDR Text Key: 232865080
• Report Number: 2016493-2021-26787
• 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: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2720-2020
• Patient Sequence Number: 1