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

Model Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2021
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.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set experienced device damage.The following information was provided by the initial reporter: iv filter tubing had a small crack in it causing iv fluid to slowly leak out and blood to back up in the picc line.No harm to patient.
Additional Manufacturer Narrative
Investigation summary: one sample was received for quality investigation.The customer complaint of component damage - crack with leak was partially verified by inspection.The infusion set was examined visually without a noticeable crack identified during the inspection.The infusion set was then primed and a leak was noted coming from one of the filter vents.A device history record review for model 2434-0007 lot number 20086789 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15aug2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The filter was sent to the supplier for further investigation of the component.During investigation of the component, the supplier indicated that the filter membrane coupon was missing on the outlet side of the filter.The manufacturing process was then reviewed with no instances of the vent membrane coupons not being present.Although a definitive root cause could not be determined, there was potential for a membrane advancement fault occurring, whereby the vent welding process would fail to advance the membrane, causing a mis-cut of the membrane roll.The vent membrane waste take-up reel has been reviewed for any potential mis-cuts over three production runs with no anomalies found.Action has been implemented following the manufacture of this batch in may 2020.Furthermore, there has been adjustments made to the vision system station to implement a modification to ensure that a defect is automatically rejected.This change was implemented in september of 2020, after the manufacture date of the reported filter batch.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set experienced device damage.The following information was provided by the initial reporter: iv filter tubing had a small crack in it causing iv fluid to slowly leak out and blood to back up in the picc line.No harm to patient.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set experienced device damage.The following information was provided by the initial reporter: iv filter tubing had a small crack in it causing iv fluid to slowly leak out and blood to back up in the picc line.No harm to patient.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 2021-11-29.H6: investigation summary: one sample was received for quality investigation.The customer complaint of component damage - crack with leak was partially verified by inspection.The infusion set was examined visually without a noticeable crack identified during the inspection.The infusion set was then primed and a leak was noted coming from one of the filter vents.A device history record review for model 2434-0007, lot number 20086789 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15aug2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in the complaint is that the filter vents were over saturated with fluid and therefore causing the leakage past the vents.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION 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 ; 8015296192
• MDR Report Key: 13044437
• Report Number: 9616066-2021-52612
• Device Sequence Number: 5449056
• Product Code: FPA
• UDI-Device Identifier: 37613203019690
• UDI-Public: 37613203019690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 04/14/2022

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 Expiration Date: 08/15/2023
• Device Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• Device Lot Number: 20086789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/04/2022; 04/14/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/22/2022; 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• 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