MAUDE Adverse Event Report: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2426-0007

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 unspecified bd intravascular administration set experienced air bubbles in line, and a defective tubing clamp.The following information was provided by the initial reporter: it was reported that the patient has an iv pump infusing fluids.Administered medication at hs (2200), pump was working a fine.Checked pump around 0520 to see if the bag needed to be replaced and noticed there were air bubbles all throughout the line past the chamber and straight to the patient.The alarm did not go off, and was pumping with no alarms going off.I do not know how long it has been pumping air into the patient.It looks like a roller clamp/iv line issue because the air bubbles are perfectly spaced out.Assessed the patient, vss, no pain or discomfort.Discontinued the line and started a new line on the other pump attached to the brain because i could not remove the channel.Changed iv pump.Put a sticker on the channel that says "do not use." there was a patient involvement but no harm.

Manufacturer Narrative

The following information has been updated/corrected: b.5.Describe event or problem: it was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced air bubbles in the line, and a defective tubing clamp.D.1.Medical device brand name: bd alaris¿ pump module smartsite¿ infusion set.D.2.Medical device manufacturer: sistemas medicos alaris, s.A.De c.V.D.4.Medical device catalog #: 2426-0007.D.4.Unique identifier (udi) #: (b)(4).D.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2021-10-07.G.1.Manufacturing location: sistemas medicos alaris, s.A.De c.V.G.5.Pma/510(k)#: k944320.Investigation: h.6.Investigation summary: one sample was returned for investigation and investigated under pr3024796.Functional testing was performed on the returned administration set.No anomalies were observed.The customer complaint that they noticed there were air bubbles all throughout the line past the chamber and straight to the patient could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced air bubbles in the line, and a defective tubing clamp.The following information was provided by the initial reporter: it was reported that the patient has an iv pump infusing fluids.Administered medication at hs (2200), pump was working a fine.Checked pump around 0520 to see if the bag needed to be replaced and noticed there were air bubbles all throughout the line past the chamber and straight to the patient.The alarm did not go off, and was pumping with no alarms going off.I do not know how long it has been pumping air into the patient.It looks like a roller clamp/iv line issue because the air bubbles are perfectly spaced out.Assessed the patient, vss, no pain or discomfort.Discontinued the line and started a new line on the other pump attached to the brain because i could not remove the channel.Changed iv pump.Put a sticker on the channel that says "do not use.".There was a patient involvement but no harm.

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12104570
• MDR Text Key: 263408470
• Report Number: 2243072-2021-01802
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/07/2021
• 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