MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 11532269

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The customer sent in product for an unspecified failure.The set was inspected for kinks, holes/tears in the tubing, and damages to the components.Visual inspection of the set noted clear liquid was observed within the set¿s 0.2 micron adult filter and throughout the set.No anomalies or evidence of damage were observed.Functional testing confirmed small droplets leaking from 0.2 micron filter top air vent (termed ¿weeping out¿).The root cause of the leak was not identified.A device history record could not be performed due to no lot number was provided by the customer.

Event Description

An unexpected tubing set was returned.There was no apparent damage to the tubing set.No further information is available.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10457534
• MDR Text Key: 205163503
• Report Number: 9616066-2020-02595
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: 10885403232343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11532269
• Device Catalogue Number: 11532269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1