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

Model Number	10798703
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
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.
Event or Problem Description
The customer reported tpn leaked from the iv set at the area of the pressure sensing disk during an infusion on a nicu patient.The leak occurred an unknown number of hours after the start of the infusion.There was no report of patient harm.
Event or Problem Description
The customer reported tpn leaked from the iv set at the area of the pressure sensing disk during an infusion on a nicu patient.The leak occurred an unknown number of hours after the start of the infusion.There was no report of patient harm.
Additional Manufacturer Narrative
The customer's report of iv set leaking was confirmed.The syringe set was pressure tested up to 30 psi.A leak was observed from the weld between the top and bottom check valve component on one side of the check valve.No leaks or damages were observed on the pressure sensing disc as reported by the customer.Visual inspection of the check valve under magnification observed the leaking check valve weld to have a slight gap between the top and bottom check valve components as compared to its opposite side.Further handling observed the top and bottom check valve components to be able to be slightly separated.No other obvious damage or issue was observed.The cause of the leak was identified as a damaged check valve component.The root cause of the damage was not identified.Device history record for model 10798703, lot 18055428 shows that the set was manufactured on (b)(6) 2018 with a total of 3,003 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.

• Brand Name: ALARIS SYRINGE MODULE SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8272861
• Report Number: 9616066-2019-00206
• Device Sequence Number: 1557295
• Product Code: FPA
• UDI-Device Identifier: 10885403234378
• UDI-Public: 10885403234378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 05/30/2021
• Device Model Number: 10798703
• Device Catalogue Number: 10798703
• Device Lot Number: 18055428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 09/10/2020
• 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: 8015,8110, TD (B)(6) 2018.