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

Model Number 11448964

Device Problem Improper Flow or Infusion (2954)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field d.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown 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 that bd alaris¿ secondary set had flow issues three times.The following information was provided by the initial reporter: verbatim : we had the same issue with another piece same product - set iv adm secondary 20gtts-bd secondary set.In total we had 3 pieces with the same issue but only two were retained.

Event Description

It was reported that bd alaris¿ secondary set had flow issues three times.The following information was provided by the initial reporter: verbatim : we had the same issue with another piece same product - set iv adm secondary 20gtts-bd secondary set.In total we had 3 pieces with the same issue but only two were retained.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07-aug-2023.Investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The primary set primed with water.A bd secondary set was primed with blue dye water and attached to the primary set.The primary bag was lowered about nine inches below the secondary bag by using a hanger.The sets were allowed to freeflow and backflow was observed.A quality notification was sent to the supplier.From the supplier investigation, particulate presence could not be confirmed through visual inspection of the assembled check valves.The check valves were inspected on offline testers and backflow failure was confirmed.The check valves were disassembled, and particulate was observed on the silicone disc.The particulate observed between the disc and the sealing surface created a leak path that led to the backflow.Ftir analysis results indicated particulates with bands associated with pvc from drip chamber.The supplier of the drip chamber completed an investigation.Since 2015 they have implemented on all assembly machines that assemble drip chambers a dedicated blow of system turbocleaner that blow and suck air in the chamber before spike is assembled.This turbulence created by the turbocleaner is meant to remove impurities inside the soft pvc chamber, and this system is working on the 100% of the parts assembled.A device history record review could not be performed because a lot number was not provided by the customer.

Manufacturer Narrative

Correction: b5: describe event or problem: it was reported that bd alaris¿ secondary set had flow issues three times.The following information was provided by the initial reporter: verbatim : we had the same issue with another piece same product - set iv adm secondary 20gtts-bd secondary set.In total we had 3 pieces with the same issue but only two were retained.D1: medical device brand name: bd alaris pump module smartsite infusion set.D4: udi #: (b)(4).D4: medical device lot #: unknown.D11: concomitant med prod data: 11448964.G.5.Pma / 510(k)#: k022209.

Event Description

It was reported that bd alaris¿ secondary set had flow issues three times.The following information was provided by the initial reporter: verbatim : we had the same issue with another piece same product - set iv adm secondary 20gtts-bd secondary set.In total we had 3 pieces with the same issue but only two were retained.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17046355
• MDR Text Key: 316491897
• Report Number: 9616066-2023-01057
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11448964
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 11448964