MAUDE Adverse Event Report: CAREFUSION SD 8120 ALARIS PCA; PUMP, INFUSION

Model Number 8120 ALARIS PCA MODULE

Device Problems Failure to Align (2522); Contamination /Decontamination Problem (2895)

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

Event Date 08/11/2020

Event Type  malfunction  

Event Description

It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.

Manufacturer Narrative

The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time.There was no reported patient involvement.

• Brand Name: 8120 ALARIS PCA
• 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: 13719246
• MDR Text Key: 286921676
• Report Number: 2016493-2022-717201
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 10885403812002
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120 ALARIS PCA MODULE
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2882-2020
• Patient Sequence Number: 1