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

Catalog Number 2420-0007

Device Problem Contamination (1120)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It was reported that there is a brown material in the cap covering the insertion site of the bd alaris pump module smartsite infusion set.The following information was provided by the initial reporter: "nurse opened package and noticed there is brown material in the cap covering the insertion site.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 there is a brown material in the cap covering the insertion site of the bd alaris¿ pump module smartsite¿ infusion set.The following information was provided by the initial reporter: "nurse opened package and noticed there is brown material in the cap covering the insertion site.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-jan-2023.H6: investigation summary a sample was returned for investigation.Through visual inspection, no defects or damages were observed on the set.The set was then primed with water and no leakage or air bubbles was observed.The set was then infused at a rate of 250 ml/hr and no there were no alarms or leakage.The defect could not be replicated.A device history record review for model 2420-0007 lot number 22075239 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to the defect not being able to be replicated, a root cause could not be determined.

• 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: 16062167
• MDR Text Key: 308365232
• Report Number: 9616066-2022-02081
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/23/2023

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: 2420-0007
• Device Lot Number: 22075239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2022
• 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