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

Model Number 2426-0007

Device Problems Inaccurate Flow Rate (1249); Air/Gas in Device (4062)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

It was reported that air in the bd alaris¿ pump module smartsite¿ infusion set line caused flow issues, infusing the potassium phosphate bag in 15 minutes rather than 1 hour.The following information was provided by the initial reporter: "beside rn started electrolyte replacement potassium phosphate bag, programmed alaris pump using drug library and set the medication to infuse over 1hr.After 15 min bedside nurse responds to pump alarm, notices pump was alarming due to air in tubing, medication bag was empty.Bedside rn notified physician, patient didn't display any physical distress.Md asked to notify pharmacist.Pharmacist notified.The author discovered the event during rounds".

Manufacturer Narrative

Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # mw5114413.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.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the tubing had improper flow and air in the line.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0007 because a lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that air in the bd alaris¿ pump module smartsite¿ infusion set line caused flow issues, infusing the potassium phosphate bag in 15 minutes rather than 1 hour.The following information was provided by the initial reporter: "beside rn started electrolyte replacement potassium phosphate bag, programmed alaris pump using drug library and set the medication to infuse over 1hr.After 15 min bedside nurse responds to pump alarm, notices pump was alarming due to air in tubing, medication bag was empty.Bedside rn notified physician, patient didn't display any physical distress.Md asked to notify pharmacist.Pharmacist notified.The author discovered the event during rounds.".

• 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 ; 8448235433
• MDR Report Key: 16427634
• MDR Text Key: 310170558
• Report Number: 9616066-2023-00246
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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