MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number	8120
Medical Device Problem Codes	Contamination (1120); Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the priming feature was "grayed out" pca pump.The clinician also reported that the device "records two decimal places that "doesn't add up with mar (medication administration record).Clinician used the example "the pump will state 2.25 however the mar will state 2.3.Education was provided to the clinician that the device is designed to round to the nearest hundredth, which would result in two decimal places.There was patient involvement but no harm.Bd has learned additional information.Bd clinical practice consultant (cpc) went onsite, and it was reported to them that the clinicians stated counts may be off due to documentation issues by the clinician.For example, if using a 20ml syringe they would put 20ml on their flow sheet, but the syringe read 19.7ml at start-up.Then they would document every hour, but they would document ¿1ml¿ even if it was actually 1.3ml because they did not assess the pump exactly an hour after the last assessment.One clinician also stated they have to stop the infusion for medication administration and that maybe the clinicians are not ¿doing the right math¿.The nicu uses syringe pumps in a lock box instead of pca pumps, they ¿don¿t usually use pca pumps¿.Cpc discussed additional potential contributing factors related to issues, e.G.Something erroneously enlarging the syringe like thick labels or added components.Clinicians stated there is no added connector on the syringe, labels for narcotics are bigger and there may be variance in how clinicians are applying them (e.G.Wrapping them around the syringe).Cpc confirmed kvo is disabled in the configs for syringe modules and priming is enabled.Clinicians confirm the bd plastipak for their 50/60ml syringe, and it is the first entry after syringe loading, but it is noted that monoject 60ml, astrazeneca 50ml and ivac 50ml also populate, and nicu does not use these syringes.
Additional Manufacturer Narrative
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : not applicable.Device evaluated by bd.

• Brand Name: ALARIS SYSTEM
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 18473715
• Report Number: 2016493-2023-253208
• Device Sequence Number: 6794268
• Product Code: MEA
• UDI-Device Identifier: 10885403812026
• UDI-Public: (01)10885403812026
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K043299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2023

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: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015
• Patient Sex: Unknown