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

Model Number 2426-0007

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.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 Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set was found misassembled.The following information was provided by the initial reporter: "misassembly".

Manufacturer Narrative

The following fields were updated due to potential lots: d4: medical device lot #: 20075744.D4: medical device expiration date: 07jul2023.H4: device manufacture date: 07jul2020.D4: medical device lot #: 20075745.D4: medical device expiration date: 08jul2023.H4: device manufacture date: 08jul2020.D4: medical device lot #: 20075746.D4: medical device expiration date: 08jul2023.H4: device manufacture date: 08jul2020.The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-mar-2023.Investigation summary: a sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The roller clamp was right below the drip chamber.Looking at the assembly drawings shows it should have been assembled lower on the set.Using the smart site ids, potential lots were determined.The device history review was completed for these potential lots.A device history record review for model 2426-0007 lot number 20075744 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2426-0007 lot number 20075745 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2426-0007 lot number 20075746 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect.A gemba walk was completed to review the manufacturing process for any potential root causes of this defect.The most probable root cause was determined to be not following the correct sequence of assembly operations.This lot was manufactured prior to corrective actions being implemented to prevent the misassembly seen on this sample.Additionally, a quality alert was displayed to reinforce the importance of following sequence assembly operation and the proper usage of fixtures.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set was found misassembled.The following information was provided by the initial reporter: "misassembly.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET
• Type of Device: 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 ; 8448235433
• MDR Report Key: 16728076
• MDR Text Key: 313195911
• Report Number: 9616066-2023-00675
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male