MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4TH GENERATION ELECTRIC WARMING CABINET

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Type  No Answer Provided  

Event Description

The user facility reported that a patient received a burn from warmed iv fluids.Steris has made multiple attempts to obtain information regarding the reported event however, the user facility will not respond.

Manufacturer Narrative

A steris service technician inspected the warming cabinet and found it to be operating properly.No issues were noted and the warming cabinet was returned to service.No additional issues have been reported.The warming cabinet is under steris service contract.Steris warming cabinets are capable of warming fluids, however the user should always follow the specific instruction of the manufacturer of the solution prior to warming any fluid.The recommended practice for warming iv and irrigation fluids in a warming cabinet: before warming iv and irrigation fluids in the warming cabinet, check with the manufacturer of the solution or fluid for their specific recommendation.The manufacturer's directions will vary, depending on the composition of the bottle material, the solution and the manufacturing process, irrigation/infusion solutions should be warmed or cooled to the temperature appropriate for the surgical need and infused fluids should be heated or cooled in devices intended for that purpose.Steris is filing this report as we are unable to confirm if the patient sought or received medical treatment.

Manufacturer Narrative

Steris was able to contact the user facility and discuss the reported event.The user facility reported that a nurse had removed a saline irrigation solution from the warming cabinet and remarked that the saline bag was very hot to the touch.Hospital personnel proceeded to use the saline irrigation solution during a patient procedure and the heated solution caused blistering to the patient's tissue.The patient procedure was subsequently cancelled and the patient sought medical treatment.The user facility stated that the cause of the reported event was due to hospital personnel using an overheated irrigation solution on the patient.The user facility did not know how long the saline irrigation solution was present in the warming cabinet.

• Brand Name: 4TH GENERATION ELECTRIC WARMING CABINET
• Type of Device: WARMING CABINET
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4753216
• MDR Text Key: 5889892
• Report Number: 1043572-2015-00036
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other