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

Catalog Number CM42500E-07

Device Problem Component Missing (2306)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported while using bd alaris¿ smartsite¿ gravity set components were missing.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: 2 sets (b)(4).(b)(4).Lot 22108416.(b)(6) 2023.No roller clamp, patient impact, and no delay in care.Defective tubing 04132023.

Manufacturer Narrative

H.3.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¿ smartsite¿ gravity set components were missing.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: 2 sets.Pn cm42500e-07.Gtin 10886403473748.Lot 22108416.04-13-2023.No roller clamp.No patient impact.No delay in care.Defective tubing (b)(6) 2023.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-may-2023.H6: investigation summary.Three samples of material number cm42500e-07 with lot numbers 22109415, 22109416 and 22109417 were submitted for quality evaluation.The customer complaint of misassembly was verified by visual inspection.Visual inspection and comparison of the assembly to the construction drawings, show that the samples were missing the roller clamp in the infusion set assembly.A device history record review for model cm42500e-07 lot number 22109415 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model cm42500e-07 lot number 22109416 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model cm42500e-07 lot number 22109417 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure seen in this complaint is a failure at the manufacturing facility to install the roller clamp on to the tubing.

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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: 16900386
• MDR Text Key: 314898141
• Report Number: 9616066-2023-00859
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/25/2023
• Device Catalogue Number: CM42500E-07
• Device Lot Number: 22109417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• 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