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

Model Number 8100

Device Problems Pumping Stopped (1503); Computer Operating System Problem (2898)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device was giving channel error message.It was reported that there was no patient involvement.Although requested, additional information was not provided.

Event Description

It was reported that the device was giving channel error message.It was reported that there was no patient involvement.Although requested, additional information was not provided.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10335999
• MDR Text Key: 205008949
• Report Number: 2016493-2020-02192
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, TD UNK.