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

Model Number	10013361
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris pump module smartsite infusion set the tubing was kinked.There was no report of patient impact.The following information was provided by the initial reporter: defective due to tubing being crimped/bent right at the drip chamber.
Event or Problem Description
It was reported while using bd alaris pump module smartsite infusion set the tubing was kinked.There was no report of patient impact.The following information was provided by the initial reporter: defective due to tubing being crimped/bent right at the drip chamber.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-feb-2023.H6: investigation summary a complaint of drip chamber being kinked was received from the customer.9 unused and 2 used samples were returned for investigation.Through visual inspection, the customer complaint was confirmed.1 used and 2 unused samples were kinked right at the drip chamber connection site to the tubing.1 used and 7 of the unused samples were kinked a little below the connection site on the tubing.A device history record review for model 10013361 lot number 21125226 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A review of the manufacturing process was performed in order to verify the current controls and to identify the potential root cause regarding the failure mode reported.With the use of a cause-and-effect diagrams, it was determined that the root cause for this failure is excessive time in an assembly fixture, causing these kinks.

• 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: 16393987
• Report Number: 9616066-2023-00219
• Device Sequence Number: 12356255
• Product Code: FPA
• UDI-Device Identifier: 50885403221963
• UDI-Public: (01)50885403221963
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/31/2023

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 Expiration Date: 12/03/2024
• Device Model Number: 10013361
• Device Catalogue Number: 10013361
• Device Lot Number: 21125226
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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