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

Catalog Number 10010453

Device Problem Separation Problem (4043)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22055926.Medical device expiration date: 21-may-2025.Device manufacture date: 16-may-2022.Medical device lot #: 22075719 medical device expiration date: 19-jul-2025 device manufacture date: 18-jul-2022.The reported lot# 22066027 was not found for the reported catalog# 10010453.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd alaris¿ pump module smartsite¿ low sorbing infusion set each from lots 22055926 and 22075719 had issues with the tpn tubing separating from the central line during the infusion.The following information was provided by the initial reporter: "tpn tubing came apart from the patient's central line.The line had been connected and infusing for 21 hours.".

Manufacturer Narrative

H6: investigation summary one sample was received for quality investigation.The customer complaint of connection issues was not verified during sample investigation.Evaluation of the sample submitted started by first visually inspecting the sample.There were no defects or damage that was noticeable on the infusion set.The infusion set was then primed and a simulated infusion was conducted at rates of 125 ml/hr and 400 ml/hr for 15 minutes at each flow rate.There were no indications of leakage, air-in-line or occlusions during the simulated infusions.A device history record review for model 10010453 lot number 22055926 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model 10010453 lot number 22075719 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.No root cause for the issue reported can be determined because the failure could not be reproduced.

Event Description

It was reported that 1 bd alaris¿ pump module smartsite¿ low sorbing infusion set each from lots 22055926 and 22075719 had issues with the tpn tubing separating from the central line during the infusion.The following information was provided by the initial reporter: "tpn tubing came apart from the patient's central line.The line had been connected and infusing for 21 hours.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ LOW SORBING 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: 15840696
• MDR Text Key: 307837557
• Report Number: 9616066-2022-01794
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021135
• UDI-Public: (01)07613203021135
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10010453
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• 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