MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC; SYSTEM, THERMAL REGULATING

Model Number 8001

Device Problems Excessive Cooling (2932); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

It was reported that a patient deviation alarm occurred.The patient had been on therapy for 55hrs.The goal temperature was 33.5 set on auto mode with an esophageal temperature probe correlating with auxiliary and rectal temperatures.No water flushes or tube feeds.The water temperature was 40 and the current patient temperature was 32.5.At times the patient was too cool and the current water temperature indicated it was warmer than the patient.Conversely when the patient was too warm, the current water temperature was cooler than the patient.

Manufacturer Narrative

The unit was not evaluated by a technician, however the customer stated that the issue was no longer persisting and was most likely resolved through clinical advice from the help line.Section h coding and manufacturing date have been updated.H3 other text: the customer stated the issue was no longer persisting.

Event Description

It was reported that a patient deviation alarm occurred.The patient had been on therapy for 55 hrs.The goal temperature was 33.5 set on auto mode with an esophageal temperature probe correlating with auxiliary and rectal temperatures.No water flushes or tube feeds.The water temperature was 40 and the current patient temperature was 32.5.At times the patient was too cool and the current water temperature indicated it was warmer than the patient.Conversely when the patient was too warm, the current water temperature was cooler than the patient.

• Brand Name: ALTRIX, DOMESTIC
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16638415
• MDR Text Key: 312351441
• Report Number: 0001831750-2023-00325
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: 07613327277555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8001
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2018
• 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