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

Catalog Number	11448964
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris secondary set back flowed to the primary bag chamber instead of administering to the patient.The following information was provided by the initial reporter: secondary medication back flowed up to the primary bags chamber instead of administering to the patient.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jun-2023.H6: 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 model and lot number was not provided by the customer.
Event or Problem Description
It was reported that the bd alaris secondary set back flowed to the primary bag chamber instead of administering to the patient.The following information was provided by the initial reporter: secondary medication back flowed up to the primary bags chamber instead of administering to the patient.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint that there was back flow could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris secondary set back flowed to the primary bag chamber instead of administering to the patient.The following information was provided by the initial reporter: secondary medication back flowed up to the primary bags chamber instead of administering to the patient.

• Brand Name: BD ALARIS SECONDARY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16882165
• Report Number: 9616066-2023-00839
• Device Sequence Number: 17957497
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

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: 11448964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 09/11/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/05/2023; 09/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown