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

Model Number 2420-0007

Device Problems Material Separation (1562); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, patient demographics was not provided.

Event Description

It was reported that there was a bubble in the pump segment.There was no patient harm.Although requested, additional information was not provided.

Event Description

It was reported that there was a "bubble" in the pump segment.There was no patient harm.Upon receipt of the involved product, the tubing appears to have separated below the drip chamber.Although requested, additional information was not provided.

Manufacturer Narrative

The customer¿s report of/that balloon in pump segment was not confirmed based on inspection, handling, and testing of the received set's silicone segment.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing, or damage to the components.The set was received with a separation at the engagement between the drip chamber and tubing components.No other issues were observed.Inspection of the separated tubing end observed insufficient to no solvent traces and evidence that the tubing was not fully inserted into the outlet spigot of the drip chamber.Dimensional analysis of the separated tubing and drip chamber spigot were observed to be within specification(s).The root cause is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.

• 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
• MDR Report Key: 9608556
• MDR Text Key: 191553463
• Report Number: 9616066-2020-00198
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 18086450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1