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

Model Number 2420-0007

Device Problem Material Deformation (2976)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # 0501290000-2023-8003.H.3.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 the bd alaris¿ pump module smartsite¿ infusion set tubing ballooned during the metronidazole infusion.The following information was provided by the initial reporter: "rn stepped into the patient's room at the time metronidazole infusion was finishing up.As she was checking the tubing, she noticed an area which was ballooning out.She immediately got the tubing out of the iv pump--no leakage or spillage noted.Infusion set was immediately sequestered and brought to quality by nurse manager.Infusion set was replaced, and no other issue has been reported.No patient harm.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 08-jun-2023.H6: investigation summary: one sample (model #2420-0007) was returned by the customer.It was reported by the customer that while checking the tubing as the infusion was finishing, there was an area that was ballooning out.The returned set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed with saline.The set was infused with the bd alaris pump and pump module at 125 ml/hr with a vtbi of 125 ml.No bulging was observed in the tubing throughout the infusion and after the infusion.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model 2420-0007 lot number 22115228 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing ballooned during the metronidazole infusion.The following information was provided by the initial reporter: "rn stepped into the patient's room at the time metronidazole infusion was finishing up.As she was checking the tubing, she noticed an area which was ballooning out.She immediately got the tubing out of the iv pump--no leakage or spillage noted.Infusion set was immediately sequestered and brought to quality by nurse manager.Infusion set was replaced, and no other issue has been reported.No patient harm.".

• 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: 16665799
• MDR Text Key: 313511735
• Report Number: 9616066-2023-00622
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 22115228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Race: Black Or African American