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

Catalog Number 47177E

Device Problem Defective Device (2588)

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

Event Date 01/20/2023

Event Type  malfunction  

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 10 bd alaris smartsite gravity set experienced tubing issues.The following information was provided by the initial reporter: i received a complaint from medline that (b)(6) is having an issue with set 47177e.

Event Description

It was reported that 10 bd alaris smartsite gravity set experienced tubing issues.The following information was provided by the initial reporter: i received a complaint from medline that baptist paducah is having an issue with set 47177e.

Manufacturer Narrative

H6: investigation summary one sample of material number 47177e was received with lot number 22079367 there were no signs of damage or defects for the sample with lot numbers 22079367.Examination of the sample with the separated drip chamber, under magnification, shows a lack of solvent at the drip chamber outlet port and on the corresponding tubing.A device history record review for model 47177e lot number 22079367 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19jul2022.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 lack solvent at the bonding location between the drip chamber outlet and tubing.This failure is caused by an incorrect use of an assembly fixture that is used to assemble the infusion set correctly.A corrective and preventative action has been issued in order to address this issue and correct the problem in future production of this infusion set.

• 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 ; 8015296192
• MDR Report Key: 16359697
• MDR Text Key: 309394518
• Report Number: 9616066-2023-00195
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235436
• UDI-Public: 10885403235436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47177E
• Device Lot Number: 22079367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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