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

Model Number 8100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

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

The customer reported the device had a check iv set error.No patient involvement.

Manufacturer Narrative

The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.A review of the device history record for sn (b)(6) was performed from date of manufacture 17nov2010 to present date 04jan2021 and note that this device has been returned for service once without correlation to the customer reported issue or service repair.Also, there were no production failures indicated on the source device.

Event Description

The customer reported the device had a check iv set error.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: 11103488
• MDR Text Key: 225341067
• Report Number: 2016493-2020-87312
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1