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

Model Number 8100

Device Problems Disconnection (1171); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not sequestered by the customer.Because no device or device logs were returned or expected to be returned, no failure investigation could be performed.The root cause of the reported failure was not identified.Patient demographics requested however not provided.

Event Description

It was reported that the facility is experiencing new issues with channel disconnects displaying corrosion on the iui connectors.The devices were inspected by biomed having concerns with staff using bleach on the devices to clean resulting in corrosion iui¿.S the customer stated there was no reports of patient harm.

• 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: 8714603
• MDR Text Key: 151028431
• Report Number: 2016493-2019-00645
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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