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

Model Number	2420-0007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Patient age and dob requested but not provided, however, the customer stated that the patient was an adult patient.
Event or Problem Description
It was reported that the tubing set leaked from a hole beneath the upper fitment in preparation of an iron infusion.The customer validated that although the infusion was being prepared for administration, the tubing set was not attached to the adult patient at the time of the event, therefore there was no patient involvement or harm caused by the event.
Additional Manufacturer Narrative
Additional information added; d.11.Correction; d.4.The customer's report of the tubing set leaked from a hole beneath the upper fitment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A small hole was observed in the silicone tubing below the upper fitment retainer ring.No gouge/crush marks were observed on the upper fitment.Reddish colored liquid was observed in the drip chamber and entire length of tubing.No other abnormalities were observed with the set.Functional and pressure testing resulted in leaking out of the location of the hole in the silicone segment tubing.The root cause of the hole could not be definitively determined.
Event or Problem Description
It was reported that the tubing set leaked from a hole beneath the upper fitment in preparation of an iron infusion.The customer validated that although the infusion was being prepared for administration, the tubing set was not attached to the adult patient at the time of the event, therefore there was no patient involvement or harm caused by the event.

• 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: 9277990
• Report Number: 9616066-2019-03121
• Device Sequence Number: 2812112
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/10/2019

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 Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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, TD (B)(6) 2019