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

Model Number	2429-0500
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
Event or Problem Description
It was reported that the fluids appeared to be dripping faster than the programmed rate.There was no patient harm.
Additional Manufacturer Narrative
Continued from d11-250ml baxter bag, lot: y314997, exp: feb21, 0.9% sodium chloride injection; 50ml baxter bag, lot: p395749, exp: aug20, ceftriaxone rta.Additional information added to: a1,d10,d11.The customer¿s complaint that fluids appeared to be dripping faster than the programmed rate was confirmed and was found to be the result of a primary administration set without a back-check valve installed.The visual inspection observed the primary administration set did not have a back-check valve installed.The back-check valve prevents iv fluids from the secondary iv to flow into the primary iv bag.No functional testing was deemed necessary due to the misassembled set.The root cause of the misassembled set was due to operator error of not following manufacturing process sequence during the set¿s assembly.
Event or Problem Description
It was reported that the fluids appeared to be dripping faster than the programmed rate during patient use.There was no patient harm.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9438360
• Report Number: 9616066-2019-03574
• Device Sequence Number: 19830372
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/05/2020
• 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: 11448964,CUROS CAPS,CEFTRIAXONE VIAL.; 8100,8015, THERAPY DATE UNKNOWN.