MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	C25006
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
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 bd alaris¿ extension set was unable to prime.The following information was provided by the initial reporter: it was reported by customer that where the bd extension set (microbore tubing) would not prime.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 2/3/2022.H.6.Investigation: one set (model #c25006) was returned by the customer.It was reported that the extension set (microbore tubing) would not prime.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Fluid was attempted to be flushed through the line.The set was unable to be primed passed the top connection point.There seemed to be an occlusion in the beginning of the line at the connector.The customer complaint can be verified.A quality notification has been sent to the manufacturer, and the sample has been sent for further investigation.The manufacturer was able to confirm the failure.The investigation determined that the possible root causes are an excess of solvent due to an incorrect selection of pins on the solvent dispensers, and that there was a failure within the analog flow meters.All operators will be informed through a quality alert as a preventative action in the next production model plan.A device history record review for model c25006 lot number 21089050 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #21089050 regarding item #c25006.
Event or Problem Description
It was reported that the bd alaris¿ extension set was unable to prime.The following information was provided by the initial reporter: it was reported by customer that where the bd extension set (microbore tubing) would not prime.

• Brand Name: BD ALARIS¿ EXTENSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13206349
• Report Number: 9616066-2021-52715
• Device Sequence Number: 14615307
• Product Code: FPA
• UDI-Device Identifier: 50885403235601
• UDI-Public: 50885403235601
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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: Other
• Device Expiration Date: 08/13/2024
• Device Model Number: C25006
• Device Catalogue Number: C25006
• Device Lot Number: 21089050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown