MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP AMBER SS 0.2M; INTRAVASCULAR ADMINISTRATION SET

Model Number	C24101E
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the air-in-line alarm sounded repeatedly during use of the as lvp 20d dehp amber ss 0.2m with "inflectra" at low flow rates.The following information was provided by the initial reporter: nurse reported "air in line" alarms repeatedly, even after changing pumps.Shared that alarms occurred during low flow rates (10, 20, and 40 ml/hr) but not at high flow rates (250 ml/hr).Medication being infused (inflectra) was a step up.
Event or Problem Description
It was reported that the air-in-line alarm sounded repeatedly during use of the as lvp 20d dehp amber ss 0.2m with "inflectra" at low flow rates.The following information was provided by the initial reporter: "nurse reported "air in line" alarms repeatedly, even after changing pumps.Shared that alarms occurred during low flow rates (10, 20, and 40 ml/hr) but not at high flow rates (250 ml/hr).Medication being infused (inflectra) was a step up".
Additional Manufacturer Narrative
H6: investigation summary: one sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Tubing was successfully primed.An infusion run was conducted at a rate of 10, 20 and 40 ml/hr for 1 hour each using pump dchu-0010 and pump module dchu-0013.All three runs were completed without issues.The customer complaint that the pump reported "air in line" could not be replicated.A root cause could not be determined because the failure was unable to be replicated.A device history record review for model c24101e lot number 20016485 was performed.The search showed that a total of 7683 units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

• Brand Name: AS LVP 20D DEHP AMBER SS 0.2M
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 11458121
• Report Number: 9616066-2021-50426
• Device Sequence Number: 19759305
• Product Code: FPA
• UDI-Device Identifier: 50885403235526
• UDI-Public: 50885403235526
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 01/18/2023
• Device Model Number: C24101E
• Device Catalogue Number: C24101E
• Device Lot Number: 20016485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1