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

Model Number	2452-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set had flow issues and was unable to prime past the first port during use.The following information was provided by the initial reporter: "as per account, iv tubing unable to prime past the first port.Iv solution filled the drip chamber and the initial portion of tubing but would not progress further despite all clamps being open and pressure being applied to the bag.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set had flow issues and was unable to prime past the first port during use.The following information was provided by the initial reporter: "as per account, iv tubing unable to prime past the first port.Iv solution filled the drip chamber and the initial portion of tubing but would not progress further despite all clamps being open and pressure being applied to the bag.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 30-jan-2023.H6: investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.The back check valve was observed to be misassembled by being inverted.The set was confirmed to not flow when attached to an infusion bag.The customer complaint that the tubing was unable to prime was replicated.A quality notification was sent to the manufacturer.From the manufacturer investigation, the potential root cause for inverted check valve is related to not correctly follow the standard work sheet for the model 2452-0007 and opportunities with the method described in the procedure for the use of the fixture to assemble the back check valve into the administration set.A device history record review for model 2452-0007 lot number 22076010 was performed.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: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION 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: 16191699
• Report Number: 9616066-2022-02214
• Device Sequence Number: 19867423
• Product Code: FPA
• UDI-Device Identifier: 50885403219878
• UDI-Public: 50885403219878
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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 Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: UNKNOWN
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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