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

Model Number 10942011

Device Problem Improper Flow or Infusion (2954)

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

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.H.4.Device manufacture date: unknown h3 other text : see h10.

Event Description

It was reported that the bd alaris¿ pump module infusion set had air in the line.The following information was provided by the initial reporter: i am the clinical educator for the surgical unit at the (b)(6) and i can confirm that the surgery unit are also experiencing the same problems as the nicu.It is difficult to provide a lot number since it has been happening over the last several months and the lot numbers of the products may have changed.The issue has also spanned over a couple of different lines and a variety of solutions including maintenance fluids, tpn, lipids and various medications.It does not appear to be one type of solution causing the issue.The 3 lines staff have been reporting the issue on are: alaris pump infusion set ref (b)(4).Alaris pump infusion set back check valve ref (b)(4).And alaris pump infusion set 0.2 micron filter ref (b)(4).Staff are having to disconnect the iv tubing from the patient and further prime the fluids through the tubing to remove the air which becomes problematic when infusing medications/tpn/lipids since it is causing a loss of those fluids.It is also increasing risk of infection to the patient.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint that they are removing all the air while priming could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the bd alaris¿ pump module infusion set had air in the line.The following information was provided by the initial reporter: i am the clinical educator for the surgical unit at the janeway and i can confirm that the surgery unit are also experiencing the same problems as the nicu.It is difficult to provide a lot number since it has been happening over the last several months and the lot numbers of the products may have changed.The issue has also spanned over a couple of different lines and a variety of solutions including maintenance fluids, tpn, lipids and various medications.It does not appear to be one type of solution causing the issue.The 3 lines staff have been reporting the issue on are: alaris pump infusion set ref 10942011, alaris pump infusion set back check valve ref 2420-0007, and alaris pump infusion set 0.2 micron filter ref 10010454.Staff are having to disconnect the iv tubing from the patient and further prime the fluids through the tubing to remove the air which becomes problematic when infusing medications/tpn/lipids since it is causing a loss of those fluids.It is also increasing risk of infection to the patient.

• Brand Name: BD ALARIS¿ PUMP MODULE 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: 16989496
• MDR Text Key: 316504780
• Report Number: 9616066-2023-01003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232402
• UDI-Public: (01)50885403232402
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931173
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10942011
• Device Catalogue Number: 10942011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1