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

Model Number	2452-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
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.The customer declined to provide patient demographic details.
Event or Problem Description
The customer reported that backflow of the secondary antibiotic into the primary bag occurred during an infusion.The user observed that the drip chamber in the primary line was filling up and there were bubbles going into the primary bag.The clinician then switched the secondary lines and it continued to bubble into the primary bag and fill the drip chamber.The entire primary line was changed and the secondary line and the iv med began to infuse properly.No patient harm was reported.The event occurred on the surgical inpatient unit, and the devices were sent to biomed who tested the pumps and no fault was identified.Biomed also tested the sets and confirmed that fluid was flowing backwards through the check valve.
Additional Manufacturer Narrative
The customer¿s report of secondary back flowed into primary was confirmed.The primary set and secondary set were visually inspected for incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed on the received sets during visual inspection.The check valve was also visually inspected under microscope.The check valve was noted to be assembled in the set correctly, and the silicone membrane was centered.During functional testing fluid and air bubbles were immediately noticed going into the primary bag.The check valve failure was due to a pvc particle found in the fluid path that prevented the silicone diaphragm from fully seating against the housing seal area.The root cause for the presence of the pvc particle was not identified.
Event or Problem Description
The customer reported that backflow of the secondary antibiotic into the primary bag occurred during an infusion.The user observed that the drip chamber in the primary line was filling up and there were bubbles going into the primary bag.The clinician then switched the secondary lines and it continued to bubble into the primary bag and fill the drip chamber.The entire primary line was changed and the secondary line and the iv med began to infuse properly.No patient harm was reported.The event occurred on the surgical inpatient unit, and the devices were sent to biomed who tested the pumps and no fault was identified.Biomed also tested the sets and confirmed that fluid was flowing backwards through the check valve.

• 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: 8639598
• Report Number: 9616066-2019-01368
• Device Sequence Number: 13911295
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 2452-0007
• Device Catalogue Number: 2452-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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,(2)SEC TUBING, TD (B)(6) 2019; NON-BD SECONDARY SET, TD (B)(6) 2019; 8100,8015,(2)SEC TUBING, TD: (B)(6) 2019.