MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB NAVINA SMART SYSTEM REGULAR; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 69009

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

Patient Problems Inflammation (1932); Loss of consciousness (2418)

Event Date 11/14/2021

Event Type  Injury  

Manufacturer Narrative

The product was not available to be returned.Wellspect healthcare been in contact with the patient's husband, and received information stating that the patient is recovering and that no surgical intervention is planned.The patient, which was suffering from cytocele and rectocele was carefully instructed under wellspect healthcare supervision in how to operate the navina smart system in performing a transanal irrigation, and did so accordingly with a good hygiene regimen.Our investigation, with the help of the patient's husband and clinicians, shows that the irrigation was not the main cause for the septic shock.The patient has also stated that there was no product-error, and therefore no root cause could be established.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.

Event Description

This incident occured in (b)(6).The patient was instructed on the 5th of november on how to perform tai.On the 14th of november, the patient was suddenly not feeling well, and was found the next day unconscious in the bathroom.The patient was brought to the hospital, admitted to the icu where ventilation and dialysis was performed on the 15th of november.The patient was extubated on the 16th of november.On the 17th of november, the patients' hands and feet were black, possibly due to an inflammation from a germ.According to the attending physician, the patient has a previous medical history with both cystocele and rectocele.

• Brand Name: NAVINA SMART SYSTEM REGULAR
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; molndal, vastra gotalands lan 43121 ; SW 43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE (A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; molndal, vastra gotalands lan 43121 ; SW 43121
• Manufacturer Contact: dino ohranovic ; aminogatan 1; p.o. box 14; molndal, vastra gotalands lan 43121 ; SW 43121
• MDR Report Key: 12907540
• MDR Text Key: 281498654
• Report Number: 3009632672-2021-00002
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K190977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 69009
• Device Catalogue Number: 6900915
• Device Lot Number: 476333
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female