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

Model Number 2420-0007

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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.Patient demographics requested however not provided.Lot not provided by customer stated: ¿unable to narrow this down to a particular lot number at this time".

Event Description

It was reported that the device alarmed during an unspecified infusion, the user open the door and noticed a bulge in the silicone segment.Although requested there was no additional event details provided or patient impact.

Event Description

It was reported that the device alarmed during an unspecified infusion.The user open the door and noticed a "bulge" in the silicone segment.Although requested, there was no additional patient or event details provided to date.

Manufacturer Narrative

The customer complaint of/that a bulge in silicone segment was confirmed per customer-provided photos that show a balloon/bulge in the silicone segment tubing near the upper fitment.Product was not returned by the customer.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.

• 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: 9416079
• MDR Text Key: 169353588
• Report Number: 9616066-2019-03512
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,THERAPY DATE UNKNOWN; 8100,8015,THERAPY DATE UNKNOWN