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

Model Number 2426-0007

Device Problems Stretched (1601); Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Information (3190)

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.Patient demographics requested however not provided.Requested lot however not provided.

Event Description

The product was received as an unexpected return with a bulge in the silicone segment.Although requested there was no other additional event details or patient impact provided by the customer.

Manufacturer Narrative

The customer¿s report was confirmed during the visual inspection as a balloon at the top of the silicone pump segment.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed that the set's silicone segment area near the upper fitment was found to be softer/weaker as compared to the rest of the silicone segment.Further visual inspection of the silicone tubing confirmed that the tubing's concentricity was within specification(s).No other anomalies or evidence of damage were observed upon initial visual inspection.Functional testing could not be confirmed.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.The root cause of the customer's report could not be identified.

Event Description

The product was received as an unexpected return with a "bulge" in the silicone segment.Although requested, there was no other additional event details or patient impact provided by the customer.

• 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: 9408225
• MDR Text Key: 169170526
• Report Number: 9616066-2019-03474
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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: 11/11/2019

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: No Information
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1