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

Model Number 2426-0007

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Cardinal health sr.Specialist; cardinal senior specialist.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Although requested, no patient information was provided.

Event Description

It was reported that tubing ballooned at the silicone segment.The event occurred while administering a saline flush.There was no patient harm.The event did not cause a delay that significantly impacted the patient outcome, no require medical or surgical intervention as a result.Although requested, no patient information was provided.

Event Description

It was reported that tubing ballooned at the silicone segment.The event occurred while administering a saline flush.There was no patient harm.The event did not cause a delay that significantly impacted the patient outcome, nor require medical or surgical intervention as a result.Although requested, no patient information was provided.

Manufacturer Narrative

Photo provided by the customer shows a bulged silicone segment.The reported suspect infusion set model 2426-0007 lot unknown, was not received for evaluation.The root cause for the source of the excessive pressure is unknown.

• 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: 9913549
• MDR Text Key: 194328739
• Report Number: 9616066-2020-01109
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

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 Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,SYRINGE, THERAPY DATE UNK