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

Model Number	10178573
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported an antibiotic was hung as a secondary infusion in the ccu.The secondary bag would alternate drips with the primary bag, and the patient was not getting the antibiotics at the correct rate, despite using a pump module.A new pump module was obtained along with new tubing, and the same thing occurred.The connection between the primary and non-bd secondary tubing was checked by two nurses, and even disconnected and reconnected for troubleshooting.The primary and the secondary infusion had an appropriate head height difference, and this was also adjusted a few times to ensure the concurrent flow was not related to head height.As a result of the concurrent flow, the infusion took longer than ordered.The secondary infusion is thought to have been levaquin, and the primary infusion was 0.9% normal saline.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of concurrent flow was not confirmed.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the received set.Functional gravity and infusion testing was successful with no instances of concurrent flow occurring.Both primary and secondary infusions completed successfully with no unintended drips or concurrent flow instances occurring.Rate accuracy testing performed with the returned administration set was found to be performing within specification.The root cause of the customer¿s report could not be identified.
Event or Problem Description
The customer reported an antibiotic was hung as a secondary infusion in the ccu.The secondary bag would alternate drips with the primary bag, and the patient was not getting the antibiotics at the correct rate, despite using a pump module.A new pump module was obtained along with new tubing, and the same thing occurred.The connection between the primary and non-bd secondary tubing was checked by two nurses, and even disconnected and reconnected for troubleshooting.The primary and the secondary infusion had an appropriate head height difference, and this was also adjusted a few times to ensure the concurrent flow was not related to head height.As a result of the concurrent flow, the infusion took longer than ordered.The secondary infusion is thought to have been levaquin, and the primary infusion was 0.9% normal saline.There was no 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: 8388317
• Report Number: 9616066-2019-00575
• Device Sequence Number: 297689
• Product Code: FPA
• UDI-Device Identifier: 07613203021111
• UDI-Public: 7613203021111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 02/07/2019

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: 10178573
• Device Catalogue Number: 10178573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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; 8100,8015, BAXTER SECONDARY SET, TD UNK