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

Model Number 8120

Device Problems Break (1069); Crack (1135); Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturer used for date of event.Device evaluated by bd service and not returned to manufacturing facility for evaluation.A review of the complaint history record was performed for the sn (b)(4) which confirmed similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 12may2015.The review was performed from the date of manufacture to the present date 24mar2021.A review of the device history record for sn (b)(4) was performed which confirmed that this device was involved in a production failure which correlates to the customer reported issue.

Event Description

It was reported that device had split nut closing properly.There was no patient involvement.

Manufacturer Narrative

Additional information: imdrf annex a, g, b, c and d grid's, manufacturer narrative (shr statement).A review of the service history record for sn 14395938 was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.

Event Description

It was reported that the device had split nut not closing properly.There was no patient involvement.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11670284
• MDR Text Key: 245536761
• Report Number: 2016493-2021-50395
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403912002
• UDI-Public: (01)10885403912002
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1