MAUDE Adverse Event Report: MEDICAL MEASUREMENT SYSTEMS B.V. SOLAR GI HRM H2O 24P TROLLEY SYSTEM; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	G3-8
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will be returned to manufacturer for evaluation but has not yet been received.An investigation is pending.
Event or Problem Description
There was a patient impact (water intoxication & seizure) and there is a formal review process being conducted by the hospital.Study commenced at 13:40 on (b)(6) 2022.They had a 6 year-old female patient who had a drop in their sodium levels from 138 mmol/l (measured prior to study) to 125mmol/l (approx.08:00 the following morning).According to the report from the doctor, the patient developed a seizure from iatrogenic hyponatremia - water intoxication.The remainder of the test was then aborted immediately afterwards (08:45 the following morning).Our customer has indicated that there were no long term effects to the patient that they are aware of, however the incident is under review in the hospital and a formal incident report is being prepared.
Additional Manufacturer Narrative
The part was received at our facilities and sent to our contracted manufacturer: demcon.The investigation described below was carried out by demcon: repair// mpp plus // sn: (b)(6); (main unit: (b)96)) // pump has negative pressure description complaint customer : pump has negative pressure investigation: the pressure for the water container is showing -490 mbar.There is dirt in the tubing to the pressure sensor, see picture (attached).Cannot see if the valves are affected by liquid.Zeroed the pressure sensor and the outgoing pressure is now equal to the displayed pressure.Possible cause of the problem: dust, liquid.Production year: 2021-11-17.Description repair: have to replace a few tubes in the unit.Therefore, we conclude that the error was caused by liquid or dirt ingress into the pressure sensor tubing.

• Brand Name: SOLAR GI HRM H2O 24P TROLLEY SYSTEM
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): MEDICAL MEASUREMENT SYSTEMS B.V.; colosseum 25; enschede 7521 PV; NL 7521 PV
• Manufacturer (Section G): MEDICAL MEASUREMENT SYSTEMS B.V.; colosseum 25; enschede 7521 PV; NL 7521 PV
• Manufacturer Contact: meghan moore ; 5420 feltl rd; minnetonka, MN 55343 ; 2182643600
• MDR Report Key: 16448312
• Report Number: 3017448360-2023-00012
• Device Sequence Number: 5734110
• Product Code: FFX
• UDI-Device Identifier: 08717775955061
• UDI-Public: 08717775955061
• Combination Product (Y/N): N
• PMA/510(K) Number: K121014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: G3-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female