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

Catalog Number 2432-0007

Device Problem Defective Device (2588)

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

Event Date 09/25/2022

Event Type  malfunction  

Event Description

It was reported while using bd alaris pump module smartsite infusion set the tubing disconnected.There was no report of patient impact.The following information was provided by the initial reporter: the tubing disconnected from the blue plastic piece at the top of the pump segment of the tubing.Looks like there is a problem with the tubing not being properly connected to the pump segment.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris pump module smartsite infusion set the tubing disconnected.There was no report of patient impact.The following information was provided by the initial reporter: the tubing disconnected from the blue plastic piece at the top of the pump segment of the tubing.Looks like there is a problem with the tubing not being properly connected to the pump segment.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 22045605 d4: medical device expiration date: 06-apr-2025 h4: device manufacture date: 06-apr-2022 d10: device available for eval yes, d10: returned to manufacturer on: 21-oct-2022 investigation summary one sample was received for quality investigation.The customer complaint of tubing defective / damaged was verified by visual examination.Investigation of the sample submitted showed that the silicone tubing of the silicone pumping segment has torn off the upper pumping fitting.The silicone tubing is torn completely away from the upper fitting.The lot number for the infusion set was reported as unknown.Using the smartsite id numbers the possible lot number for this infusion set is 22045605.A device history record review for model 2432-0007 lot number 22045605 was performed.The search showed that a total of (b)(6) was built on 06apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in this complaint is the misloading of the infusion set into the alaris pump.Similar complaints that have shown the same damage to the pumping segment have been caused by loading the bottom of the pumping segment first and then stretching the silicone tube to load it, causing for the tubing to tear.Additionally if the upper pumping segment in not installed correctly, closing the pump door can cut the silicone tubing.

• 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 ; 8015296192
• MDR Report Key: 15700594
• MDR Text Key: 303257068
• Report Number: 9616066-2022-01656
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232329
• UDI-Public: 10885403232329
• 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: 11/03/2022

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
• Device Operator: Other
• Device Catalogue Number: 2432-0007
• Device Lot Number: 22045605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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