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

Model Number	2200-0500
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag, lot: y325811, exp: jun21, 20meq potassium chloride in 5% dextrose and 0.9% sodium chloride injection; therapy date (b)(6) 2020.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
It was reported that pump alarm ¿air in line¿ but after troubleshooting, no air in line found.The nurse stated that the patient came up from the or needing iv fluids.The nurse spiked and hung new iv fluids with a new primary tubing set.The blue iv pump module gave an "air in line" message.The iv tubing fluids were switched to a total of 3 blue iv pump modules that all gave the same air in line error message.The nurse spiked iv fluids with a new primary set, which then worked on the iv pump without error message.Although requested, no additional event and/or patient information was provided.
Additional Manufacturer Narrative
Additional information: d.11.
Event or Problem Description
It was reported that the pump alarmed ¿air in line¿, but after troubleshooting, no air in line was found.The nurse stated that the patient came up from the or needing iv fluids.The nurse spiked and hung new iv fluids with a new primary tubing set.The blue iv pump module gave an "air in line" message.The iv tubing fluids were switched to a total of (3) blue iv pump modules that all gave the same air-in-line error message(s).The nurse spiked iv fluids with a new primary set, which then worked on the iv pump without any error message.Although requested, no additional event and/or patient information was provided.
Event or Problem Description
It was reported that the pump alarmed ¿air in line¿, but after troubleshooting, no air in line was found.The nurse stated that the patient came up from the or needing iv fluids.The nurse spiked and hung new iv fluids with a new primary tubing set.The blue iv pump module gave an "air in line" message.The iv tubing fluids were switched to a total of (3) blue iv pump modules that all gave the same air-in-line error message(s).The nurse spiked iv fluids with a new primary set, which then worked on the iv pump without any error message.Although requested, no additional event and/or patient information was provided.
Additional Manufacturer Narrative
The customer's report of an air in line alarm occurring with use of the set was confirmed.Air bubbles were observed within the set.The set sample was inspected for kinks, holes/tears in the tubing or damages to the components.There were two tears in the silicone segment directly below the upper fitment component.There was a crush marking along the upper fitment.No other damage or issue was observed.Although damage was observed, the set was re-primed.Close inspection observed fluid leaking from the tears.No leak or issue was observed from anywhere else.Although leaks were observed, the set was loaded into a lab pump module and an infusion was programmed at a rate of 125ml for one hour.Approximately ten minutes into the infusion, an air in line alarm occurred.The cause of the alarm was due to tears on the silicone segment component.The root cause of the damage was not identified.The device history record search for model 2200-0500 could not be conducted due to no lot number being provided.

• 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: 9811442
• Report Number: 9616066-2020-00651
• Device Sequence Number: 2890452
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 06/19/2020; 06/25/2020
• 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: 8015, 8100, PRI TUBING; SEE H.10