MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; NEONATAL ARCTIC GEL PADS

Catalog Number 318-02-02

Device Problems Inaccurate Flow Rate (1249); Deformation Due to Compressive Stress (2889)

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

Event Date 06/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the customer witnessed the connection of the neonatal pad to the arctic sun device.The patient was on the pads for 2 hours with no concerns of flow issues and was resuscitated.It was noted that once the patient was stabilized the clinical team noticed that the arctic suns flow rate was dropped to 0.0 lpm.The patients temperature was also dropped to 33.6 c.The nurse called the customer service and was discussed through checking the connections emptying the pad and filling the pads.The customer informed to change the pad if the pressure did not stabilize as there was a potential air leak coming from the pad affecting the pressure.The customer called back and spoke to the team leader stating that they turned the device off to warm the patient.The arctic sun struggled to return the water from the pad to the device.The customer suggested that they change over the pad and to perform a slow controlled rewarm.The patient was on the arctic sun device being slowly rewarmed and they were having no issues with the new pad.The customer spoke to the complainant that the patient was on the target and there were no further issues.

Manufacturer Narrative

The reported event was confirmed as design related.Visual inspection noted one neonatal artic gel pad was received.Visual evaluation noted the tubing with the connection line pointing to the exterior of the pad was kinked on return which makes this sample applicable to capa.This fails to meet specifications, stating there should be no bends in the tube that reduce the internal diameter of the hose.The root causes for this failure are diet task analysis filled out incorrectly due to inadequate directions and misunderstanding of ¿use interface¿, inadequate procedure(s) either thru diet or usability which provides minimum instruction for evaluating user interface changes to existing products and inadequate design verification testing that failed to evaluate functionality in all use cases (both connector orientations) and all affected products (neonatal pads were not tested).A review of the device history record was not required as this investigation has been addressed by a capa.The labeling was not completed as they are addressed by existing capa.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 actual/suspected device was inspected.

Event Description

It was reported that the customer witnessed the connection of the neonatal pad to the arctic sun device.The patient was on the pads for 2 hours with no concerns of flow issues and was resuscitated.It was noted that once the patient was stabilized, the clinical team noticed that the arctic sun flow rate was dropped to 0.0 lpm.The patient's temperature was also dropped to 33.6 c.The nurse called the customer service and was discussed through checking the connections, emptying the pad and filling the pads.The customer informed to change the pad if the pressure did not stabilize as there was a potential air leak coming from the pad affecting the pressure.The customer called back and spoke to the team leader stating that they turned the device off to warm the patient.The arctic sun struggled to return the water from the pad to the device.The customer suggested that they change over the pad and to perform a slow controlled rewarm.The patient was on the arctic sun device being slowly rewarmed, and they were having no issues with the new pad.The customer spoke to the complainant that the patient was on the target and there were no further issues.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: NEONATAL ARCTIC GEL PADS
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12174238
• MDR Text Key: 261764564
• Report Number: 1018233-2021-04237
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 318-02-02
• Device Lot Number: NGER4713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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