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	10010453
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem 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: (b)(4)- lipid tubing broke.Blood back up and lipids leaked on bed.
Additional Manufacturer Narrative
It was reported that the set separated at the filter.One sample model 10010453 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the outlet filter.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the most possible root cause is due to incorrect solvent application by personnel or due to the solvent dispenser not working properly.Lot reported was manufactured on october 05th, 2023, before actions state implemented.Update of procedure to state a bushing change sequence and dispenser revision.Completed on (b)(6) 2023.A quality alert was created and communicated on january 16th, 2024, to the involved personnel to reinforce the correct follow up to the sws and correct amount of solvent application.A dhr was performed for the possible lots 23085002 and 23075470: a device history record review for model 10010453 lot number 23085002 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jul2023.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 10010453 lot number 23075470 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 31jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional info.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET
• Common Device Name: 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: 18609853
• Report Number: 9616066-2024-00135
• Device Sequence Number: 7565535
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: (01)37613203021143
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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
• Operator of Device: Other
• Device Catalogue Number: 10010453
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown