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

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive, as the device was not returned for evaluation.A potential failure mode could be ¿air leakage into the system.¿ a potential root cause for this failure could be "user cuts or punctures pads or pad lines." the lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the z300-unknown arctic gel pads ifus are found to be adequate based on past reviews.

Event Description

It was reported that while a cardiac arrest patient was being cooled on the arctic sun, some of the patient's blood was sucked up into the arctic sun pads and device.The complainant noted that chest compressions had been performed for four hours and that the patient had been bleeding a lot.She had no information on where the blood was coming from.The nurse requested information on how to remove the blood from the device.Additional information was received from the facility on 13jan2020 that the pads had allegedly broke, which allowed the blood to enter the device.Technical support explained to the facility that if the pads broke, it was unlikely that the flow rate would be high enough to suck blood into the device.A call was received from a clinical equipment expert and a clinical risk specialist on 15jan2020.They stated that the pads had been disposed of and the pad size was unknown.She denied that the pads were placed on top of any injuries and that the pads did not cause any injuries.She also stated that an auto-compression device had been used on top of the chest pads and was unsure if it was affecting the flowrate.She was unable to provide any information on where exactly the blood was coming from on the patient.She noted "the blood was everywhere; the patent was in very critical condition." they wanted to send the device in to be internally decontaminated.It was noted that the device was tested and was found to have no issues.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9672109
• MDR Text Key: 177838788
• Report Number: 1018233-2020-00776
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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
• Date Manufacturer Received: 01/13/2020
• 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: Initial
• Patient Sequence Number: 1