MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Model Number FLT-112S, FLT-112

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

Situation: multiple clinical sites reported multiple issues with the disposable cartridges/kits used with the hologic fluent management systems.1) leaking of fluent cartridges- this has been occurring for 1.5 years and the sites continuously work with the local rep.Initially the rep informed the site they had and would exchange cartridges.No notice or recall was communicated.It is now across all sites and all lot numbers, but sites have come to expect this from the product, so they have not been reporting.2) difficulty loading cartridges due to failure of machine sensor to detect the cartridge heads requiring work-arounds.The machine has a sensor to detect a white strip inside the cartridge heads.When the sensor detects the presence of the cartridge, it engages a magnet to load and start the cartridge.The white strip on the cartridges is coming very faded in new cartridges, and the clinical staff have developed a work-around to engage the sensor by putting a piece of white paper or sticker inside the cartridge head.This poses its own risks but otherwise the machine will not function or load the cartridge.Similar reports for this machine and cartridges found in maude.Most recent events: [redacted date] cartridge would not load, multiple attempts to troubleshoot with company: [redacted date] leaking, [redacted date] leaking 2nd occurrence, [redacted date] cartridge would not load.Product: disposable procedure kit, manufacturer: hologic, manufacturer item number: flt-112s or flt-112, used with machine/device model: flt-100 (new), or rm-flt-100 (remanufactured).Individual sites have attempted to resolve this issue with the manufacturer for the past 1.5 years with no resolution or formal acknowledgement/notice of the defect to date.Samples provided to rep frequently/most of the time given the cost to sites, they made efforts to return so they could get financial credit.Assessment: a) clinical engineering has ruled out the machines as a root cause for the leaks.Hologic still exchanged our machines and gave us refurbished/remanufactured (rm) machines and the same issue is occurring.B) potential for patient harm is a concern.No known significant safety events have been reported internally at (b)(6) due to this issue.This is included but not limited to fluid overload, too much fluid being left inside the patient with the management system unable to perform its primary function of intake and output properly.C) (b)(6) supply chain messaged to periop sites on [redacted date] to report any and all issues with these machines so we can document the failures and report them, also use them to talk through with the manufacturer.We are escalating this to hologic quality this week now that the situation is clearly understood and product ids have been obtained.Manufacturer response for fluid management disposable cartridge, fluent fluid management cartridge/kit (per site reporter).See event report section.

Event Description

Situation: multiple clinical sites reported multiple issues with the disposable cartridges/kits used with the hologic fluent management systems.1) leaking of fluent cartridges- this has been occurring for 1.5 years and the sites continuously work with the local rep.Initially the rep informed the site they had and would exchange cartridges.No notice or recall was communicated.It is now across all sites and all lot numbers, but sites have come to expect this from the product, so they have not been reporting.2) difficulty loading cartridges due to failure of machine sensor to detect the cartridge heads requiring work-arounds.The machine has a sensor to detect a white strip inside the cartridge heads.When the sensor detects the presence of the cartridge, it engages a magnet to load and start the cartridge.The white strip on the cartridges is coming very faded in new cartridges, and the clinical staff have developed a work-around to engage the sensor by putting a piece of white paper or sticker inside the cartridge head.This poses its own risks but otherwise the machine will not function or load the cartridge.Similar reports for this machine and cartridges found in maude.Most recent events: [redacted date] cartridge would not load, multiple attempts to troubleshoot with company.[redacted date] leaking.[redacted date] leaking 2nd occurrence.[redacted date] cartridge would not load.Product: disposable procedure kit.Manufacturer: hologic.Manufacturer item number: flt-112s or flt-112.Used with machine/device model: flt-100 (new), or rm-flt-100 (remanufactured).Individual sites have attempted to resolve this issue with the manufacturer for the past 1.5 years with no resolution or formal acknowledgement/notice of the defect to date.Samples provided to rep frequently/most of the time given the cost to sites, they made efforts to return so they could get financial credit.Assessment: a) clinical engineering has ruled out the machines as a root cause for the leaks.Hologic still exchanged our machines and gave us refurbished/remanufactured (rm) machines and the same issue is occurring.B) potential for patient harm is a concern.No known significant safety events have been reported internally at [redacted name] due to this issue.This is included but not limited to fluid overload, too much fluid being left inside the patient with the management system unable to perform its primary function of intake and output properly.C) [redacted name] supply chain messaged to periop sites on [redacted date] to report any and all issues with these machines so we can document the failures and report them, also use them to talk through with the manufacturer.We are escalating this to hologic quality this week now that the situation is clearly understood and product ids have been obtained.Manufacturer response for fluid management disposable cartridge, fluent fluid management cartridge/kit (per site reporter) see event report section.

Event Description

Situation: multiple clinical sites reported multiple issues with the disposable cartridges/kits used with the hologic fluent management systems.1) leaking of fluent cartridges- this has been occurring for 1.5 years and the sites continuously work with the local rep.Initially the rep informed the site they had and would exchange cartridges.No notice or recall was communicated.It is now across all sites and all lot numbers, but sites have come to expect this from the product, so they have not been reporting.2) difficulty loading cartridges due to failure of machine sensor to detect the cartridge heads requiring work-arounds.The machine has a sensor to detect a white strip inside the cartridge heads.When the sensor detects the presence of the cartridge, it engages a magnet to load and start the cartridge.The white strip on the cartridges is coming very faded in new cartridges, and the clinical staff have developed a work-around to engage the sensor by putting a piece of white paper or sticker inside the cartridge head.This poses its own risks but otherwise the machine will not function or load the cartridge.Similar reports for this machine and cartridges found in maude.Most recent events: [redacted date] cartridge would not load, multiple attempts to troubleshoot with company.[redacted date] leaking.[redacted date] leaking 2nd occurrence.[redacted date] cartridge would not load.Product: disposable procedure kit.Manufacturer: hologic.Manufacturer item number: flt-112s or flt-112.Used with machine/device model: flt-100 (new), or rm-flt-100 (remanufactured).Individual sites have attempted to resolve this issue with the manufacturer for the past 1.5 years with no resolution or formal acknowledgement/notice of the defect to date.Samples provided to rep frequently/most of the time given the cost to sites, they made efforts to return so they could get financial credit.Assessment: a) clinical engineering has ruled out the machines as a root cause for the leaks.Hologic still exchanged our machines and gave us refurbished/remanufactured (rm) machines and the same issue is occurring.B) potential for patient harm is a concern.No known significant safety events have been reported internally at [redacted name] due to this issue.This is included but not limited to fluid overload, too much fluid being left inside the patient with the management system unable to perform its primary function of intake and output properly.C) [redacted name] supply chain messaged to periop sites on [redacted date] to report any and all issues with these machines so we can document the failures and report them, also use them to talk through with the manufacturer.We are escalating this to hologic quality this week now that the situation is clearly understood and product ids have been obtained.Manufacturer response for fluid management disposable cartridge, fluent fluid management cartridge/kit (per site reporter) see event report section.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 18118338
• MDR Text Key: 327907200
• Report Number: 18118338
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2023

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
• Device Model Number: FLT-112S, FLT-112
• Device Catalogue Number: FLT-112S
• Device Lot Number: 23E02RN, 23G18RD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/22/2023; 11/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1