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

Model Number	2429-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 25 ml baxter bag p391235, exp oct 20, 0.9% sodium chloride injection.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.Patient age and dob requested but not provided, however the customer stated that the patient was an adult.
Event or Problem Description
It was reported that the rn observed that the tubing set was leaking at the site of the blue safety clamp during an iron infusion on an adult patient.The customer later stated that there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported that the rn observed that the tubing set was leaking at the site of the blue safety clamp during an iron infusion on an adult patient.The customer later stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report of tubing set leaked at the blue safety clamp was confirmed.During visual inspection of the set received it was observed immediately that the silicone segment had a tear near the lower fitment.Visual examination under microscope noted no crush marks to the upper blue fitment.No other anomalies were noted during visual inspection.Functional testing observed a leak during priming.The cause of the leak was due to a tear in the silicone segment.The root cause of the customer's report could not be determined.

• 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: 8820408
• Report Number: 9616066-2019-02075
• Device Sequence Number: 19589807
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 05/24/2022
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 19056816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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, TD (B)(6) 2019; 8100,8015, TD (B)(6) 2019