MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	20350ET
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the tubing set leaked from the round disk on the filter during priming of normal saline, before it was connected to the patient.Event occurred in outpatient infusion center.There was no patient involvement.
Additional Manufacturer Narrative
The customer¿s report that the set leaked from the filter vent while priming was confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Examination under magnification observed areas of the 0.2 micron adult filter's lower vent membrane not being adhered to the filter (as compared to the upper vent membrane).Functional testing confirmed leaking from the lower filter vent.The cause of the leak was due to an area of the filter's lower vent membrane not being adhered to the filter.The root cause was due to a supplier manufacturing issue.The device history record search for model 20350et lot 19085494 shows the set was manufactured on 30aug2019 for a total of (b)(4) units.There was no related quality notification issued during the production build of this set.
Event or Problem Description
It was reported that the tubing set leaked from the round disk on the filter during priming of normal saline, before it was connected to the patient.Event occurred in outpatient infusion center.There was no patient involvement.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9866023
• Report Number: 9616066-2020-01036
• Device Sequence Number: 16283921
• Product Code: FPA
• UDI-Device Identifier: 10885403229756
• UDI-Public: 10885403229756
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 02/26/2020

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: 08/30/2022
• Device Model Number: 20350ET
• Device Catalogue Number: 20350ET
• Device Lot Number: 19085494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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: PRI TUBING, THERAPY DATE: UNK.; PRI TUBING, THERAPY DATE: UNK.