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

Model Number	10013072
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 500ml baxter bag, lot y322057, exp jan21, 5% dextrose injection; spiros adapter; non-bd secondary set; 250ml b braun bag lot j9n167, exp 1/21, 5% dextrose injection.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 or Problem Description
It was reported that tubing had a small hole and leaked while infusing cyclosporine on the bmt (bone marrow transplant) unit.The infusion of cyclosporine was running at 126 ml/hour as a secondary infusion.No patient harm occurred.
Event or Problem Description
It was reported that the tubing section that goes in the pump had a small hole that leaked while infusing cyclosporine on the bmt (bone marrow transplant) unit.The infusion of cyclosporine was running at 126 ml/hour as a secondary infusion.No patient harm occurred.
Additional Manufacturer Narrative
The customer's report that tubing had a small hole and leaked was confirmed.The primary set sample was inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a tear in the silicone segment directly below the upper fitment component.No other damage or issue was observed.Functional testing confirmed leaking from the tear.The cause of the leak was identified as due to a tear in the silicone segment.The root cause of the observed damage was not identified.The device history record search for model 10013072 could not be conducted due to no lot number being provided.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9868100
• Report Number: 9616066-2020-01037
• Device Sequence Number: 560950
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10013072
• Device Catalogue Number: 10013072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100,NON-BD EXT, TD (B)(6) 2020