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

Model Number 2420-0007

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that "a set that randomly backed up into the bag".No additional information was provided.

Event Description

It was reported that; "a set that randomly backed up into the bag".No additional information has been made available.

Manufacturer Narrative

The customer¿s report the set randomly backed up into the bag was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was also observed inside the tubing throughout the set.No other anomalies were observed with the set.Functional testing did not replicate any secondary backflow with the administration set or any issues.Pressure testing also found no anomalies with the returned set.Functional testing was performed and no leaks or issues were observed.The customer's experience was not replicated as the set primed and infused completely during functional testing with no secondary backflow or any other issues observed.

Event Description

It was reported that; "a set that randomly backed up into the bag".No additional information has been made available.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9140016
• MDR Text Key: 160733253
• Report Number: 9616066-2019-02713
• 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,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2019; 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUROS CAP, THERAPY DATE UNKNOWN.; CUROS CAP, THERAPY DATE UNKNOWN