MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES; ARCTIC SUN FLUID DELIVERY LINE

Model Number 50000000E

Device Problems Inaccurate Flow Rate (1249); Use of Device Problem (1670)

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

Event Date 02/26/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that a neonate was cooling on the arctic sun device for the last hour.Nurse reported that this was only the second time the device was being used, and it sounded alarm 113 (reduced water temperature control).Mss explained what alarm 113 (reduced water temperature control) meant.They were currently getting x-rays and placing intravenous lines.Nurse asked mss to call back in 15 minutes as they were unable to troubleshoot it at the moment.And 15 minutes later, water reservoir level was at 5 bars.Nurse drained 500ml of water from the right drain port.Patient temperature was 32c, target temperature was 33.5c, water temperature was 39.8c and flow rate was 0.7lpm.Water control showed that inlet pressure was -7 psi and circulation pump command was 28 percent.Mss had the nurse look for bends or kinks in the pad tubing and fluid delivery line (fdl) and nurse saw no bends or kinks in the pad tubing.The fluid delivery line (fdl) was wrapped around the device.Nurse straightened out the fluid delivery line (fdl) tubing and the flow rate rose to 1lpm.Mss recommended the nurse to find a way to support the fluid delivery line (fdl), so it does not bend and the flow rate stays up.

Manufacturer Narrative

The reported issue was confirmed.The device was not returned.The root cause of the reported issue was isolated to user related.It was known that the device did not meet specifications and the device was influenced by the reported failure.The device was in use on a patient.The serial number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿low water flow confirm that all of the pad connectors are fully seated in the fluid delivery line manifolds.If not fully seated, reseat connectors.Check the pads for foam-to-foam folds or buckles created during placement.If folds or buckles, smooth out and reapply pads.Check the pad lines for kinks or occlusions.If kinks or occlusions, straighten lines to remove.Bd recommends use of fluid delivery line straps to keep lines from kinking.Check the pad connectors for a continuous stream of air bubbles.If air bubbles are observed, disconnect one pad at a time and wait one minute.If flow increases during pad disconnect, the pad is damaged.Replace the damaged pad with a universal pad.¿ 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 a neonate was cooling on the arctic sun device for the last hour.Nurse reported that this was only the second time the device was being used, and it sounded alarm 113 (reduced water temperature control).Mss explained what alarm 113 (reduced water temperature control) meant.They were currently getting x-rays and placing intravenous lines.Nurse asked mss to call back in 15 minutes as they were unable to troubleshoot it at the moment.And 15 minutes later, water reservoir level was at 5 bars.Nurse drained 500ml of water from the right drain port.Patient temperature was 32c, target temperature was 33.5c, water temperature was 39.8c and flow rate was 0.7lpm.Water control showed that inlet pressure was -7 psi and circulation pump command was 28 percent.Mss had the nurse look for bends or kinks in the pad tubing and fluid delivery line (fdl) and nurse saw no bends or kinks in the pad tubing.The fluid delivery line (fdl) was wrapped around the device.Nurse straightened out the fluid delivery line (fdl) tubing and the flow rate rose to 1lpm.Mss recommended the nurse to find a way to support the fluid delivery line (fdl), so it does not bend and the flow rate stays up.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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 a neonate was cooling on the arctic sun device for the last hour.Nurse reported that this was only the second time the device was being used, and it sounded alarm 113 (reduced water temperature control).Mss explained what alarm 113 (reduced water temperature control) meant.They were currently getting x-rays and placing intravenous lines.Nurse asked mss to call back in 15 minutes as they were unable to troubleshoot it at the moment.And 15 minutes later, water reservoir level was at 5 bars.Nurse drained 500ml of water from the right drain port.Patient temperature was 32c, target temperature was 33.5c, water temperature was 39.8c and flow rate was 0.7lpm.Water control showed that inlet pressure was -7 psi and circulation pump command was 28 percent.Mss had the nurse look for bends or kinks in the pad tubing and fluid delivery line (fdl) and nurse saw no bends or kinks in the pad tubing.The fluid delivery line (fdl) was wrapped around the device.Nurse straightened out the fluid delivery line (fdl) tubing and the flow rate rose to 1lpm.Mss recommended the nurse to find a way to support the fluid delivery line (fdl), so it does not bend and the flow rate stays up.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Type of Device: ARCTIC SUN FLUID DELIVERY LINE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13860355
• MDR Text Key: 287688109
• Report Number: 1018233-2022-01481
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• 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,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 734-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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