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

Catalog Number 10010454

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite low sorbing infusion set was damaged.The following information was received by the initial reporter with the following verbatim.Rcc received a complaint via email.Filter crack while trying to give a ppn.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that there was a crack on the filter.One sample model 10010454 was returned for investigation.The set was examined for defects and abnormalities.A crack was seen going down the middle of the filter.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the supplier.From the supplier investigation, the investigation determined that vents with compromised hydrophobic properties can create an airlock condition inside the filter increasing internal pressure if air cannot be vented efficiently.Potential scenarios exist from treatments and exposures that occur post filter assembly that can compromise proper vent functionality.These exposures could include contact on the vent with tube bonding solvent, gamma irradiation or other sterilization exposures, and/or low surface tension fluids, especially those that may contain elements of alcohol or lipids that may inhibit air venting resulting in internal pressure increasing.A device history record review for model 10010454, possible lots number 24025004, 24025559 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

No additional info.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19169980
• MDR Text Key: 341279405
• Report Number: 9616066-2024-00609
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: (01)07613203015806
• 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: 08/12/2024

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: 10010454
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 08/12/2024
• Supplement Dates FDA Received: 08/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1