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

Catalog Number 2432-0007

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set had unregulated flow and caused an over-infusion.The patient received a calcium gluconate bolus, a saline bolus, and repeated blood work as a result.The following information was provided by the initial reporter: "this tubing was involved in a possible over infusion event that occurred on (b)(6) 2022.Our medical engineering department is investigating the lvp module that was involved in the event.Was this used on a patient? was there any patient harm? yes this was used on the patient.The patient received a calcium gluconate bolus, they became unwell and required a saline bolus and repeat blood work to ensure the labs had stabilized.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 13-feb-2023.H6: investigation summary: one sample (model # 2432-0007) was returned for investigation by the customer.It was reported by the customer that "this tubing was involved in a possible over infusion event that occurred." the set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was loaded into an alaris pump and an infusion was started for 1 hr at 125 ml/hr flowing into an empty beaker.It was verified that beaker has about 125 ml in it after infusion completed.Further functional testing was performed by using a primary bag filled with clear saline which was then used to prime the returned set.A bd secondary set (mat # 10014881) was connected to a bag filled with a blue dye/water mixture, and then connected to the primary set.The sets were set up in a secondary infusion configuration with the fluid level of the secondary bag higher than the primary bag fluid level, and all of the clamps closed.The secondary set was primed for 1hr at rate of 125ml with the secondary roller clamp fully opened.Fluid flow was controlled using the primary roller clamp, the blue dye/water mixture fluid from the secondary bag was found to be flowing through the check valve into the primary bag, indicating the check valve was failing to prevent backflow.The issue of back flow can be verified.A quality notification was sent to the supplier.The issue of over infusion could not be replicated, however the issue of back flow can be replicated.A device history record review for model 2432-0007 and lot number 22085596 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.The check valve was inspected for backflow on bench testers and backflow failure was confirmed.The check valve was disassembled, and particulates were visually identified on the silicone disc.There were three particulates: two small white particulates and one large black particulate.The particulates were sent to our internal lab for analysis.The particulates observed between the disc and the sealing surface created a leak path that led to the backflow.Results indicated particulate associated with medication, silicone polymer, and acrylic.Medication and silicone polymers are not a part of the supplier¿s manufacturing processes.Given the findings summarized above, the supplier is taking steps to prevent further occurrence of this issue.The supplier continues to implement 100% backflow verification during the assembly process and will continue to ensure controls are in place to minimize quality issues.After investigation by manufacturer, the potential root cause for back flow due to particles in check valve could be related to: contamination during the proximal automated machine process generated for the same component; supplier processes; final user.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set had unregulated flow and caused an over-infusion.The patient received a calcium gluconate bolus, a saline bolus, and repeated blood work as a result.The following information was provided by the initial reporter: this tubing was involved in a possible over infusion event that occurred on (b)(6) 2022.Our medical engineering department is investigating the lvp module that was involved in the event.Was this used on a patient? was there any patient harm? yes this was used on the patient.The patient received a calcium gluconate bolus, they became unwell and required a saline bolus and repeat blood work to ensure the labs had stabilized.".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16316241
• MDR Text Key: 309010110
• Report Number: 9616066-2023-00150
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232329
• UDI-Public: 10885403232329
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2432-0007
• Device Lot Number: 22085596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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
• Patient Outcome(s): Required Intervention