MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number 3180202

Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)

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

Event Date 08/16/2021

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 neonatal pad was taken out of the package and placed under the patient.The pad had been connected to the arctic sun and the therapy started.After filling the pad, a leak with water leakage was observed at the transition of the tube to the pad.The therapy was stopped and the pad was replaced.The therapy could then be continued.

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.Although lot number is unknown, confirmed visually that this neonatal pad has the pre-capa design.The root causes for this failure are: diet task analysis filled out incorrectly due to inadequate directions per cqa-std-64 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 ; 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).The device history record and labeling review was not required as it has been addressed by a capa.Correction: h.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 neonatal pad was taken out of the package and placed under the patient.The pad had been connected to the arctic sun and the therapy started.After filling the pad, a leak with water leakage was observed at the transition of the tube to the pad.The therapy was stopped and the pad was replaced.The therapy could then be continued.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PADS
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12447147
• MDR Text Key: 270550176
• Report Number: 1018233-2021-05522
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3180202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other