MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH PRISMAFLO IIS; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number PF2300NA

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypothermia (1915); Respiratory Failure (2484)

Event Date 02/07/2021

Event Type  No Answer Provided  

Event Description

A patient in the intensive care unit was on continuous renal replacement therapy (crrt) and the crrt heating unit was inadvertently turned off and this was unrecognized.This resulted in the patient becoming hypothermic, requiring inotropes and intubation.Crrt heater was off or malfunctioning which led to a hypothermic event for the patient and further hypotension and eventual intubation due to respiratory decompensation.It's unclear if the hypothermia is the full cause of his deterioration, however, it likely did affect his stability.The nurse was moving the child, took brake off crrt cart and slid cart a little when this happened the heater became unplugged.Where the plug goes into the back of the heater became loosened enough that there was no flow of electricity and the heater turned off.The plug was still in the back of the heater when it was discovered the heater was off.The nurse was in charge of managing the device, however the heater was not directly being operated.This was classified as severe temporary harm to the patient.This is all the information available.

• Brand Name: PRISMAFLO IIS
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; 12011 mosteller road; cincinnati OH 45241
• MDR Report Key: 11453027
• MDR Text Key: 238873905
• Report Number: 11453027
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PF2300NA
• Device Catalogue Number: PF2300NA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA