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

Model Number	2430-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics was not provided.
Event or Problem Description
It was reported at pacific medical center that the tubing set leaked.It leaked from the connection at the proximal end of filter while infusing.Although requested, additional information was not provided.
Additional Manufacturer Narrative
The customer¿s report that the set leaked from the filter was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Examination under magnification observed a small crack on the filter component.Functional testing confirmed leaking from the 0.2 filter.The source of the leak is due to a crack on the filter component.The root cause of the crack damage could not be determined.Device history record for model 2430-0500 could not be performed due to no lot number being provided by customer.
Event or Problem Description
It was reported at (b)(6) that the tubing set leaked.It leaked from the connection at the proximal end of filter while infusing.Although requested, additional information was not 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: 9931005
• Report Number: 9616066-2020-01221
• Device Sequence Number: 2900961
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/12/2020

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: 2430-0500
• Device Catalogue Number: 2430-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: 8100,8015, THERAPY DATE (B)(6) 2020