MAUDE Adverse Event Report: SUNMED SUNMED; 19 MM DISPOSABLE BACTERIAL/VIRAL FILTER

Model Number BF102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Many factors may have contributed to the bv filter become occluded such as humidity, patient size, length of procedure regardless of the cause medical intervention was needed to prevent the increase of the resistance of the bv filter which interfered with adequate ventilation.Although there was no patient harm due to the filter being replaced and the healthcare personnel were able to provide ventilation to the patient this event will be reported.Based on this information this is a reportable event.

Event Description

This case was being done in our covid (b)(6) with dr.(b)(6) (appendectomy).Patient o2 levels were decreasing.Anesthesia (dr.(b)(6)) had problem with maintain o2 sats.Backup anesthesia (dr.(b)(6)) came to assist.Once the bacterial filter was removed anesthesia was able to ventilate patient.I am verging for documentation purposes per (b)(6) manager of operating room.After discussing with dr.(b)(6) we will trend any further issues and address at that time.It is believed to possibly been a bad filter.

Manufacturer Narrative

The complaint could not be confirmed by a formal investigation, because the affected product was not returned.Complaint history for this part number was reviewed for the last 24 months.No similar complaints have been reported and this issue is not trending at this time.It is difficult to give a definitive root cause without returned product for formal investigation.However, the most likely root cause of this issue is an insufficient amount of mek bonding material used in production of the device, as well as a higher than recommended tension placed on the device during removal.Customer follow up was performed via email, including a formal letter.The supplier was notified of the event.The failure mode (r9) disconnection of breathing circuit is identified on the risk analysis file (ra-47) and the severity of harm for this failure mode is considered a hazardous (9) risk.This meets the risk threshold for carb review and will be discussed at the next carb meeting.

Event Description

This case was being done in our covid or #8 with (b)(6) (appendectomy).Patient o2 levels were decreasing.Anesthesia ((b)(6)) had problem with maintain o2 sats.Backup anesthesia ((b)(6)) came to assist.Once the bacterial filter was removed anesthesia was able to ventilate patient.I am verging for documentation purposes per (b)(6) manager of or.After discussing with (b)(6) we will trend any further issues and address at that time.It is believed to possibly been a bad filter.

• Brand Name: SUNMED
• Type of Device: 19 MM DISPOSABLE BACTERIAL/VIRAL FILTER
• Manufacturer (Section D): SUNMED; 2710 northridge dr., nw.,; suite a; grand rapids 49544
• MDR Report Key: 11820357
• MDR Text Key: 253987235
• Report Number: 1314417-2021-00005
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BF102
• Device Lot Number: N/A
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other