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

Model Number	C24104E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported that during an infusion of nacl, the tubing leaked at the hub connection closest to the patient.There was no report of patient harm.Although requested, no other information has been received.
Event or Problem Description
The customer reported that during an infusion of nacl, the tubing leaked at the hub connection closest to the patient.There was no report of patient harm.Although requested, no other information has been received.
Additional Manufacturer Narrative
The customer report that the tubing leaked was confirmed; however not with the used set received but with the new sets received.Received was a partial used set model c24104e.Also received were a total of 37 unopened packages of the same model sets- one for lot 18055267, and 36 for lot 18066824 visual inspection showed no anomalies.No leaks were identified on the used set during functional and pressure testing.14 representative samples from the received new samples from lot 18066824 were tested.Testing on one of the new sets observed an immediate leak at the engagement of the tubing and male luer lock components.On another new set, attempted removal of the exit luer cap caused separation at the same noted engagement.The root cause was identified as both insufficient solvent being applied at the engagement of the tubing and a gap related to improper assembly due to equipment and/or operator error.

• 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: 8313670
• Report Number: 9616066-2019-00350
• Device Sequence Number: 2120636
• Product Code: FPA
• UDI-Device Identifier: 10885403235535
• UDI-Public: 10885403235535
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/14/2019

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: 06/26/2021
• Device Model Number: C24104E
• Device Catalogue Number: C24104E
• Device Lot Number: 18066824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1