MAUDE Adverse Event Report: CONVATEC INC FMS SIGNAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 418000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Death (1802); Sepsis (2067); Pressure Sores (2326)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Affiliation: (b)(6).Based on the available information, this event is deemed to be a serious injury.On (b)(6) 2020 a clinical specialist covering the west area met with the customer on this issue.The product was used off label per section c.Insertion of device: inflate the balloon with up to 45ml of fluid by slowly depressing the syringe plunger.With the insertion finger removed, the signal¿ dome will indicate once the balloon has reached the optimal fill level for the anatomy.There may be cases where the signal¿ dome will not indicate if the space in the rectum is large.Under no circumstances should the balloon be inflated with more than 45ml of fluid.If the signal¿ dome indicates at less than 30 ml of fluid, withdraw the fluid and reposition the balloon in the rectal vault.After repositioning, fill the balloon as described above.Do not fill with more than 45ml of fluid.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Since there was not lot number provided, we are unable to determine the specific manufacturing site.Both potential manufacturing site numbers are listed.To date no additional information has been received.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

It was reported a bed ridden ¿patient with pressure injury".Patient with diagnosis of "encephalopathy and cirrhosis".The device was placed due to the patient receiving "lactulose enemas.The device was placed on (b)(6) 2020.The device was in use ¿for fourteen plus (14+) days¿ when a "stage 3" pressure wound was noted.The reporter stated, ¿forty-five (45) milliliters) ml was instilled and unknown amount thereafter.¿ a peri-wound assessment notes incontinence associated dermitis (iad), which was cleansed with saline.Cavilon advanced skin sealant was used to treat the condition.The device was discontinued on (b)(6) 2020 when the patient expired.It was further reported that the device was not related to the cause of death.¿the patient was profoundly anemic.The patient passed with sepsis and multiorgan failure with unknown origin.Family decided to withdraw care after twenty-five (25) days with no improvement in patient condition." the user facility continued the usage of the device, even after a wound was identified.There were no photographs depicting the reported complaint issue submitted by the complainant.

• Brand Name: FMS SIGNAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10423253
• MDR Text Key: 209401707
• Report Number: 1049092-2020-00162
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66