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

Model Number	2426-0007
Medical Device Problem Codes	False Alarm (1013); Improper Flow or Infusion (2954); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2019
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 product be received for evaluation.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report which states, "bolus iv fluids ordered for pt, new tubing obtained and tried 3 separate channels but kept alarming saying "air-in-line".Changed tubing and problem was resolved.Fda safety report 10# (b)(4).".
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report which states, "bolus iv fluids ordered for pt,new tubing obtained and tried 3 separate channels but kept alarming saying "air-in-line".Changed tubing and problem was resolved.Fda safety report 10# ''(8)(4)''." it was reported that patient was receiving a primary infusion of a normal saline bolus when the device continued to alarm for air in line.The user tried 3 different devices then changed out the tubing without further issues.The customer confirmed that there was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the device continued to alarm for air in line was not confirmed.Functional testing did not to replicate an air bolus within the administration set or any air-in-line alarms.Pressure testing also found no anomalies with the returned set.The device pumps and pcu that were in use at the time of the customer event were not returned for investigation.Functional testing was performed by repriming the set using one lab iv bag filled with blue dye water.The set reprimed successfully via gravity and showed no signs of air entering the lines.The set was then loaded into a lab pump module with device settings for air bolus limited set to 250 l and for accumulated air - enabled.An infusion rate was not provided, therefore the primary infusion was programmed at a rate of 125ml/h and vtbi of 125ml.The primary infusion completed with no alarms or any air-in-line issues noted.No air bolus were observed throughout the set.The set was pressure tested while submerged underwater.Air pressure was incrementally increased from 5 psi to 30 psi.No leaks were observed.The root cause was not identified.

• 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: 8791687
• Report Number: 9616066-2019-01949
• Device Sequence Number: 2666066
• Product Code: FPA
• UDI-Device Identifier: 07613203011853
• UDI-Public: 7613203011853
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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 Expiration Date: 04/24/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19046758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: 8100,8015, THERAPY DATE: (B)(6) 2019