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

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Device Sensing Problem (2917)

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

Event Date 04/13/2021

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 temperature was not reading on the arctic sun device and stated that the temperature cable was in temperature 2 outlet.The user switched the cable to the temperature port 1.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was determined to be an user error in connecting the temperature cable to the incorrect temperature port.The user switched the cable to temperature port 1.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown.The instructions for use were found adequate and state the following: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Ifu: connections guideline: the image of the control module system is provided in the ifu.Use only medivance approved cables and accessories with the arctic sun® temperature management system control module.Connect the fluid delivery line, patient temp 1 cable, patient temp 2 cable (optional) and fill tube to the back of the control module." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the temperature was not reading on arctic sun device and stated that the temperature cable was in temperature 2 outlet.The user switched the cable to temperature port 1.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Type of Device: UNKNOWN TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11781840
• MDR Text Key: 249204744
• Report Number: 1018233-2021-02612
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other