MAUDE Adverse Event Report: CAREFUSION ALARLIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION

Model Number	10013072
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported a leak at back check valve.It did not reach the patient as it detached prior to use.No patient harm was reported.
Additional Manufacturer Narrative
The customer¿s report of leak at back check valve was confirmed based on visual inspection.A tear was observed on the tubing sleeve at the engagement of the check valve outlet and tubing.Further inspection observed a gap at the same engagement.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Although the tear was observed, the set was reprimed and fluid leaked from the tear.No other leak was observed.A slight tug of the set's tubing engagements observed no separation.The root cause was not identified.
Event or Problem Description
Received a copy of the customer's cmdsnet program report from health canada which states, ¿leak at back check valve - product did not reach the patient.".

• Brand Name: ALARLIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9123640
• Report Number: 9616066-2019-02748
• Device Sequence Number: 2597191
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 05/03/2022
• Device Model Number: 10013072
• Device Catalogue Number: 10013072
• Device Lot Number: 19055340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1