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

Model Number	8100
Medical Device Problem Codes	Break (1069); Contamination (1120); Corroded (1131); Crack (1135); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a "pump error" message followed by "error with tubing" message.Per report, "when opening the channel, the tubing was found suctioned to itself".The clinician switched the channel and opened and closed the clamp on tubing to fix the pressure problem.Flushed with short tubing without difficulty.There was patient involvement but no harm.Although requested no additional information will be provided by the customer, no devices will be returned.
Additional Manufacturer Narrative
A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Investigation summary: the root cause of the reported "pump error" message was found to be due to an occluded fluid side; however, the root cause of the occluded fluid side was not found during investigation.The results of testing the suspect pump module identified both pressure sensors to be operating within specification.The suspect pump module was attached to the returned pcu and both were powered on.The pump module was selected and programmed for a ¿basic¿ infusion at the rate of 500ml/hr with a volume to be infused (vtbi) of 1000ml (infusion duration of 2 hours).The infusion was then started.No issues were noted in this instance.Light pressure was applied to the bottle and patient side pressure sensor pads.The voltage increased to a maximum of 4.9 volts for both pressure sensors.This test was made a total of ten (10) times, after each release, both pressure sensors returned to their original voltage values.The pressure sensors passed this test.During the log review of the pcu event logs the suspect pump module (s/n: (b)(6) was not found on any date registered, only the pump module (s/n: (b)(6) and the pump module (s/n: (b)(6) were observed on the reported event date.The pcu (s/n: (b)(6) was the last observed to be attached to the returned pump module) the review of the suspect pump module error logs identified an error code: 240.4150.0 (sensor broken high failure).The error log indicated that there were 704 malfunctions between 28oct2024 and 06may2025.The most recent occurred on (b)(6) 2025 at 1:38 pm.(see figure 2).On (b)(6) 2025 at 1:36 pm the unit was selected, an infusion with a rate = 134 ml/hr and a vtbi = 16 ml, the infusion was started.From 1:37 pm to 1:38 pm the device alarm for pump chamber blocked, the infusion was restarted, the device alarmed for occluded fluid side five (5) times, then the infusion was restarted, subsequently, there was a channel malfunction and the infusion was stopped.At 1:40 pm the pump module was channeled off.Per the alaris pressure sensor tip sheet, to avoid pressure sensor damage, do not apply pressure to the center of the pressure sensors.The device was in use for treatment purposes as intended per 21 cfr 820.198(d)(2).Notes to repair center: please re-torque all screws.Repair center should follow their normal processing procedures for the device, checking for any incidental issues prior to returning it to the customer.Designated complaint handling unit (dchu) will not over the costs associated with any incidental findings or components that have been physically abused.Root cause: the root cause of the reported pump error message was found to be due to an occluded fluid side; however, the root cause of the occluded fluid side was not determined during investigation.No root cause was determined during laboratory testing or through a log review.Note that imdrf annex a0404, a0401, a1801, a040502, c07, c0601, c070606, d01, d15, d02, g04067, g0301201, g02017 codes not associated with the root cause but identified as reportable malfunctions observed on the device during investigation are unrelated to the reported issue.These other failures presumptively did not cause or contribute to the reported issue.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.

• 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: 22667878
• Report Number: 2016493-2025-101559
• Device Sequence Number: 17063393
• Product Code: FRN
• UDI-Device Identifier: 10885403211423
• UDI-Public: (01)10885403211423
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2008
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2718-2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015.
• Patient Sex: Unknown