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

Model Number 8120

Device Problem Fail-Safe Problem (2936)

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

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

Customer advocacy received a copy of the customer's maude report from the fda which stated, "ft was able to use a key on our alaris/bd carefusion model 8120 rca pumps to divert dilaudid and these keys can be bought of the internet this is the second time that this has happened and was able to determine it was the patient who had a key that she could use." there was no reported patient harm.

• Brand Name: ALARIS PCA MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11797064
• MDR Text Key: 249688726
• Report Number: 2016493-2021-503896
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2021
• 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; PCA TUBING