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

Model Number	10933805
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2020
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 normal saline under the drip chamber before use.It was reported that this occurred in a chemo outpatient department, 7n.There was no patient involvement.
Additional Manufacturer Narrative
Additional information provided: d.11 the customer¿s complaint of tubing set leaked from the drip chamber was confirmed.Visual inspection of the set noted a gap from the tubing set to the drip chamber, indicating that the expected tubing was not fully inserted.Examination under magnification observed traces of insufficient solvent applied at the tubing insertion engagement.Functional and pressure testing confirmed small droplets of fluid leaking from the tubing to the drip chamber outlet port.No other anomalies were observed with the set.Dimensional analysis found the tubing measured to be within specification the root cause of the leak is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.Device history record for model 10933805 lot 19076939 shows that the set was manufactured on 30 july 2019 with a total of 11,523 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
Event or Problem Description
It was reported that the tubing set leaked normal saline under the drip chamber before use.It was reported that this occurred in a chemo outpatient department, 7n.There was no patient involvement.

• 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: 9924811
• Report Number: 9616066-2020-01222
• Device Sequence Number: 3272431
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 07/30/2022
• Device Model Number: 10933805
• Device Catalogue Number: 10933805
• Device Lot Number: 19076939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 07/06/2020
• 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: 8015,8100, THERAPY DATE (B)(6) 2020; NON-BD GREEN CUROS ALCOHOL DISINFECTANT CAP