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

Model Number 2420-0007

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information requested but not provided.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.

Event Description

It was reported that there were three (3) tubing sets that developed a ballooned in a silicon segment and separated prior to use on a patient.There was no patient involvement.

Manufacturer Narrative

The customer¿s report of tubing sets that developed a balloon in a silicon segment was confirmed during visual inspection.The separation was observed at the engagement between the lower fitment and the silicone segment tubing.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Further visual inspection of the silicone segment observed retainer ring indentations in the correct location on the tubing.No damage was observed on the retainer ring.It was also observed that the silicone segment tubing was discolored and was weakened just below the upper fitment.The remaining portion of the set starting with the lower fitment component was not received from the customer.Functional testing was not performed due to the separation and missing lower section of the set.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.

Event Description

It was reported that there were three (3) tubing sets that developed a "balloon" in the silicone segment, and separated prior to use on a patient.Subsequently, there was no patient involvement.

• 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: 9601502
• MDR Text Key: 192026236
• Report Number: 9616066-2020-00185
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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 Expiration Date: 10/28/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19107162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1