MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

Device Problems No Display/Image (1183); Device Sensing Problem (2917)

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

Event Date 11/04/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that in first call they told patient just returned from procedure and nurse noted patient temperature was not registering on the arctic sun device.Verified that the probe was plugged into the patient temperature 1 port.Suggested they plug the temperature sensor foley into a bedside monitor to verify the probe itself was working.If the probe registers on the bedside monitor, then the issue was the temperature cable plugged into the arctic sun.Nurse told they had to locate the cable to plug into the bedside monitor to check.They do not have another device and they were not sure they had another temperature cable either.Suggested contact local facilities to see if they had a cable they could utilize.On the following call nurse answered and told that they were able to plug probe into bedside monitor and confirmed the mistake was the temperature cable.Asked about getting another cable and they asked for representative contact information.Explained shipping was not available outside of m-f business hours.Representative do not typically carry spare cables with them and could not guarantee they were in the hospital.Best solution was to contact a nearby facility.Encouraged them to order multiples to have on hand for instances such as that one.On the other call nurse stated they figured it out.They called earlier because the temperature was not registering.They changed the device thinking it was the device, but that did not work either.They changed the foley probe and how they had a patient temperature.No action needed.They were trying to deliver therapy on device but were getting a low air leak message.Flow was good on their first device.They changed devices because they stopped getting a patient temperature read.They determined the foley was the underlying problem.Flow rate was 1lpm, inlet pressure was 3.1psi, command pump was 100%.Walked nurse through disconnecting and reconnecting pads using proper technique.Inlet pressure was remained around -3psi, flow rate was 1lpm, system hours were 1770 and pump hours were 1678.Suggested changing back to the original device since flow was good on that device.Asked nurse to call back if flow continued to be low on new device.If flow was good send that device to biomed.No further calls.

Event Description

It was reported that in first call they told patient just returned from procedure and nurse noted patient temperature was not registering on the arctic sun device.Verified that the probe was plugged into the patient temperature 1 port.Suggested they plug the temperature sensor foley into a bedside monitor to verify the probe itself was working.If the probe registers on the bedside monitor, then the issue was the temperature cable plugged into the arctic sun.Nurse told they had to locate the cable to plug into the bedside monitor to check.They do not have another device and they were not sure they had another temperature cable either.Suggested contact local facilities to see if they had a cable they could utilize.On the following call nurse answered and told that they were able to plug probe into bedside monitor and confirmed the mistake was the temperature cable.Asked about getting another cable and they asked for representative contact information.Explained shipping was not available outside of m-f business hours.Representative do not typically carry spare cables with them and could not guarantee they were in the hospital.Best solution was to contact a nearby facility.Encouraged them to order multiples to have on hand for instances such as that one.On the other call nurse stated they figured it out.They called earlier because the temperature was not registering.They changed the device thinking it was the device, but that did not work either.They changed the foley probe and how they had a patient temperature.No action needed.They were trying to deliver therapy on device but were getting a low air leak message.Flow was good on their first device.They changed devices because they stopped getting a patient temperature read.They determined the foley was the underlying problem.Flow rate was 1lpm, inlet pressure was 3.1psi, command pump was 100%.Walked nurse through disconnecting and reconnecting pads using proper technique.Inlet pressure was remained around -3psi, flow rate was 1lpm, system hours were 1770 and pump hours were 1678.Suggested changing back to the original device since flow was good on that device.Asked nurse to call back if flow continued to be low on new device.If flow was good send that device to biomed.No further calls.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "sensor wire too weak".The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; suite 200; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18182192
• MDR Text Key: 328673095
• Report Number: 1018233-2023-08347
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other