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

Model Number 2420-0007

Device Problem Backflow (1064)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris pump module smartsite infusion set experienced a check valve malfunction.The following information was provided by the initial reporter: lab testing confirmed the presence of phosphate in the primary bag (which was supposed to have only saline), indicating backflow occurred in this event.Lvp + secondary set programmed to run sodium phosphate as a secondary infusion over 2 hours, completed over 1 hour.Different lvp + same secondary set programmed to run as a secondary infusion over 1 hour.Medicine dripped really fast and was infused in ~15 minutes.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 15-feb-2022.H.6.Investigation: one sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Sample was primed with normal saline.A bd secondary set primed with blue dye water was attached to the sample and allowed to flow.No observation of back flow was observed.The customer complaint that the lab testing confirmed the presence of phosphate in the primary bag (which was supposed to have only saline), indicating backflow occurred in this event could not be replicated.The root cause could not be determined because the issue could not be replicated.The root cause could not be determined because the issue could not be replicated.A dhr was performed for the 5 possible lots: a device history record review for model 2420-0007 lot number 21115845 was performed.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 2420-0007 lot number 21115911 was performed.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 2420-0007 lot number 21115891 was performed.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 2420-0007 lot number 21115842 was performed.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 2420-0007 lot number 21115922 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A chc was performed for 5 possible lots: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21115845 regarding item #2420-0007 a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21115911 regarding item #2420-0007 a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21115891 regarding item #2420-0007 a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21115842 regarding item #2420-0007 a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21115922 regarding item #2420-0007.

Event Description

It was reported that the bd alaris pump module smartsite infusion set experienced a check valve malfunction.The following information was provided by the initial reporter: lab testing confirmed the presence of phosphate in the primary bag (which was supposed to have only saline), indicating backflow occurred in this event.Lvp + secondary set programmed to run sodium phosphate as a secondary infusion over 2 hours, completed over 1 hour.Different lvp + same secondary set programmed to run as a secondary infusion over 1 hour.Medicine dripped really fast and was infused in ~15 minutes.

• 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: 13482872
• MDR Text Key: 286728284
• Report Number: 9616066-2022-00092
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/15/2022
• 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