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

Model Number 8100

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No product returned.Because no device or device logs were returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

It was reported during a site visit that a channel disconnect occurred on an alaris pump module on the telemetry/medical/surgical unit.Clorox hydrogen peroxide cleaner disinfectant wipes are commonly used to clean both the pumps and the iui connectors.The staff was instructed to avoid cleaning the iuis with the hydrogen peroxide cleaner.The device was taken to biomedical engineering for evaluation.Event date was unknown.

• Brand Name: ALARIS® PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9733309
• MDR Text Key: 180315666
• Report Number: 2016493-2020-00236
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• 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 the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8015, THERAPY DATE UNKNOWN