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

Model Number	2425-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, no additional information about the patient, medication, or event was provided.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that there was an unspecified tubing leak.
Additional Manufacturer Narrative
The customer¿s report of an unspecified tubing leak was not confirmed.The suspect product was not returned for investigation, however (45) new, unused associate model 2425-0500, lot 19046941 were received from the customer.Visual inspection showed no anomalies.Functional testing showed no anomalies.Pressure testing showed no anomalies.The root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that there was an unspecified tubing leak.

• 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: 8931110
• Report Number: 9616066-2019-02411
• Device Sequence Number: 16206737
• Product Code: FPA
• UDI-Device Identifier: 07613203021395
• UDI-Public: 7613203021395
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 04/29/2022
• Device Model Number: 2425-0500
• Device Catalogue Number: 2425-0500
• Device Lot Number: 19046941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1