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

Model Number	10015489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Patient demographics requested however not provided.
Event or Problem Description
It was reported that an unspecified fluid was infusing, after 20 ml.Volume infused ,the user noticed a leak at an unknown location.The user changed out the set with the same lot and had no further issues.
Event or Problem Description
It was reported that an unspecified fluid was infusing, after 20 mls volume infused ,the user noticed a leak at an unknown location.The user changed out the set with the same lot and had no further issues.
Additional Manufacturer Narrative
The customer¿s report of a tubing leak was confirmed.Visual inspection of the set noted a tear/puncture on the tubing.No other obvious damages or issues were observed.Functional testing confirmed leaking.The cause of the leak was due to a damaged tubing.The root cause was not identified.

• 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: 8527439
• Report Number: 9616066-2019-01066
• Device Sequence Number: 11237749
• Product Code: FPA
• UDI-Device Identifier: 07613203021050
• UDI-Public: 7613203021050
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2022
• Device Model Number: 10015489
• Device Catalogue Number: 10015489
• Device Lot Number: 19025805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1