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 Component (2292)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris smartsite gravity set was damaged the following information was received by the initial reporter with the following verbatim: one of our intermountain facilities is reporting an issue/concern with an item that it is purchased from your company.Situation: issue: the tubing used for a stem cell boost snapped right below the chamber during the infusion.

Manufacturer Narrative

It was reported that the tubing snapped just below the drip chamber.One sample model 47177e, lot 23079289 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the drip chamber.No other defects or abnormalities were observed.The customer complaint was verified.From the manufacturer's investigation, the potential root cause could be related to failures of the solvent dispenser and assembly process does not have support that ensures the correct dimension and alignment of the tubing to ensure solvent is dispensed on the tubing.H3 other text : see h10 below.

Event Description

No additional info.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19056983
• MDR Text Key: 340461429
• Report Number: 9616066-2024-00540
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235436
• UDI-Public: (01)10885403235436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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: 47177E
• Device Lot Number: 23079289
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/07/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1