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

Model Number	418000
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Codes	Skin Irritation (2076); Tissue Damage (2104); Pressure Sore/Ulcer (2326); Blood Loss (2597)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.Additional patient/event details have been requested but, not provided.Should additional information become available a follow-up report will be submitted.The lot number was not provided.Therefore, we are unable to determine the specific third party manufacturing site.Both potential manufacturing site numbers are listed.Fda registration number reporting site:(b)(4).Third party manufacturing site: (b)(4).
Event or Problem Description
It was reported that the patient was being treated with a flexi-seal signal fms device because of diarrhea.The fms signal device was inserted on (b)(6) 2018.It was unknown if a rectal exam was performed prior to insertion, as there was no record of rectal examination found.The customer indicated that prior to inserting the fms device, the patient¿s perianal-rectal area was red, and there were many big hemorrhoids.It was further reported the patient¿s skin was very thin due to treatment with steroids.The customer reported that the fms was replaced the (b)(6) 2018 and no ulcers were observed that day.Additionally the customer reported ¿45 ml was entered in to the cuff when applying fms signal.A few days before removal of fms signal, 5 ml was withdrawn from the cuff because of minor leakage.On (b)(6) 2018, the nurse noted the patient¿s rectum was very ¿open¿ and noted at least 3 pressure ulcers in the area between perineum, sphincter and ampulla recti.The pressure ulcers were reported to be category 2-3.It was further reported that the nurse indicated the fms balloon was ¿placed very low, maybe placed in the sphincter area but she is not sure and maybe it has fallen a bit out or maybe not placed correctly.¿ it was reported that it was difficult for the nurse to quantify the amount of bleeding.Bleeding was observed from the pressure ulcers as well as form the hemorrhoids.It was reported that ¿the patient was very ill (had multi organ failure (mof)) and treatment was stopped and replaced with palliative treatment, so no specific pressure ulcer treatment was provided.¿ the patient expired on an unspecified day following the event due to ¿her bad general condition (mof).¿.

• Brand Name: FMS SIGNAL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 7441325
• Report Number: 1049092-2018-00124
• Device Sequence Number: 1636869
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (Y/N): N
• PMA/510(K) Number: K112342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Nurse
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDICATION
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR