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

Model Number	24602-B007T
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the secondary infusion unexpectedly started to back flow into the drip chamber of the primary line.Although requested, there were no further details or information provided and no report of harm.
Additional Manufacturer Narrative
The customer¿s report of back flow into the drip chamber of the primary line was not confirmed.When proper head height differentials are used for secondary infusion set-up and when the primary set tubing clamp is engaged.The primary set was visually inspected for incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed on the received set during visual inspection.Functional testing resulted in fluid flowing without incident of backflow.This set does not come with a check valve and any secondary infusion needs to have the primary set tubing clamp engaged.The root cause of the customer¿s report was not determined.The suspect set was not returned for investigation.
Event or Problem Description
It was reported that the secondary infusion unexpectedly started to back flow into the drip chamber of the primary line.Although requested, there were no further details or information provided and no report of patient harm.

• 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: 8724992
• Report Number: 9616066-2019-01715
• Device Sequence Number: 1860235
• Product Code: FPA
• UDI-Device Identifier: 10885403240980
• UDI-Public: 10885403240980
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Model Number: 24602-B007T
• Device Catalogue Number: 24602-B007T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: SEC TUBING, THERAPY DATE UNK; SEC TUBING, THERAPY DATE UNK