MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX IV FILTER EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	FS116
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was "a trend of malfunctioning filter microbore intravenous infusion tubing that began starting 2023.The tubing leaks at the filter or requires excess pressure to prime/infuse fluid.Has impacted flow of medications such as inotropes and sedation on critically ill pediatric cardiovascular patients in the operating room or intensive care unit.One patient in 2023 had epinephrine leaking in the operating room during open heart surgery, possibly contributing to a delay in coming off of bypass.Re-escalated to the manufacturer on that day, and they came on site 2023 to retrieve product.At that time, they mentioned that the filter is provided by another company.Have not stopped use of the product but have re-educated staff on the manufacturer's instructions for use with ongoing issue." there was no patient harm reported.No patient names available.Product failures occurred during infusion, noticed hours or days into infusion.
Additional Manufacturer Narrative
D4: lot number, expiration date, e1: phone, and h4: device manufacture date is unknown, no information has been provided to date.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6 - evaluation codes: updated.Device evaluation: no product sample nor pictured were received for analysis; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number has been provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
Gcm received user facility mandatory medwatch (mw5150083) on 30-jan-2024 that stated: "a trend of malfunctioning filter microbore intravenous infusion tubing began starting 2023 (smiths medical fs116).Reported to the manufacturer (icu medical) in 2023.Has been documented on patient 7.Tubing leaks at the filter or requires excess pressure to prime/infuse fluid.Has impacted flow of medications such as inotropes and sedation on critically ill pediatric cardiovascular patients in the operating room or intensive care unit.One patient in 2023 had epinephrine leaking in the operating room during open heart surgery, possibly contributing to a delay in coming off of bypass.Re-escalated to the manufacturer on that day, and they came on site 2023 to retrieve product.At that time, they mentioned that smiths/icu medical does not make the filter themselves, but it is provided by another company.Utilized networking listserves to identify if other facilities have experienced the same issue.At least one hospital) has experienced the same issue in the same timeframe with a different brand product that contains a filter that looks almost identical to the one that we used.Have not received update from manufacturer on their internal investigation.Have not stopped use of the product but have re-educated staff on the manufacturer's instructions for use with ongoing issue.".Vab arratigue 05-feb-2024.Update: gcm received an email from icumed sales representative on 9-feb-2024 stating that there was no patient harm reported.No patient names available.Product failures occurred during infusion, noticed hours or days into infusion.Jmontecino 14-feb-2024.

• Brand Name: MEDEX IV FILTER EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18793668
• Report Number: 9616567-2024-00038
• Device Sequence Number: 20656810
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: 10351688510969
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: FS116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/07/2024; 09/12/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/04/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPINEPHRINE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown