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

Model Number	10012283
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product 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
It was reported that sets leaked from the filter during patient use.It was further confirmed during follow-up, that there was no patient harm as a result of this event.
Event or Problem Description
It was reported that sets leaked from the filter during patient use.It was further confirmed during follow-up, that there was no patient harm as a result of this event.The event occurred in the nicu.
Additional Manufacturer Narrative
The customer¿s report that set leaked from the filter was confirmed.Received from the customer was one used burette primary set; 10012283, lot number is unknown.The set was visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Visual inspection of the set noted light yellow liquid was observed within the micron filter and throughout the set above the filter.Sticky residue was also observed on the surface of the set¿s filter.No anomalies or evidence of damage were observed on the filters or the sets upon visual inspection.Functional testing resulted in the set not repriming due to an occlusion.Pressure testing confirmed small droplets leaking from the micron filter¿s air vent (termed ¿weeping out¿).The root cause of the leak was not identified.

• 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: 9215893
• Report Number: 9616066-2019-02908
• Device Sequence Number: 13998538
• Product Code: FPA
• UDI-Device Identifier: 10885403233692
• UDI-Public: 10885403233692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 03/02/2021
• Device Model Number: 10012283
• Device Catalogue Number: 10012283
• Device Lot Number: 18035035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1