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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS Back to Search Results
Lot Number NGEQY269
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
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 arctic sun device was reading low flow when user just initiated therapy.The target temperature was 33c, patient temperature was 36.3c, water temperature was 6.9c and flow rate was fluctuating between 1.7 l/min to 2.2 l/min.Patient was getting a central line and preparing to transfer to intensive care unit (icu).Mss explained to regional nurse to purge pads, disconnected and reconnected it.The four pads were connected appropriately without kinks.The regional nurse stated the flow rate was still fluctuating.Mss asked the regional nurse if they had time to do deep troubleshooting.The user stated they would get another device.Per call back, the nurse stated 2nd arctic sun device was in intensive care unit (icu) and was ready to transport patient.The nurse was going to tag device and send it to biomed for checks.The regional nurse told intensive care (icu) when they connect patient to device if they had low flow, it might be a pad issue.Mss told regional nurse would check with intensive care unit (icu).Mss walked through troubleshooting on second device.The patient temperature was 36.1 c with flow rate around 1.5 l/min to 1.7 l/min.Mss asked regional nurse to disconnect pads one at a time.The user disconnected right thigh pad and flow rate was 1.7 l/min after a few minutes.Left thigh disconnected and the flow rate was 1.0 l/min after a few minutes.Left chest disconnected and the flow rate was 1.0 after a few minutes.Right chest disconnected and the flow rate was 1.0 after a few minutes.Mss recommended regional nurse to change out right thigh pad with a universal pad and to call back if the issue was not resolved and asked regional nurse to save right thigh in case field assurance requested.It was confirmed that the issue was with arctic gel pads not with the arctic sun device.Per additional information received on 01jun2021, nurse stated that the arctic gel pads would be returned.Therapy was completed with a new set of pads and the arctic sun device was not sent to biomed.Per additional information received on 27jul2021, there were two sets of faulty pads.One pad set had an issue with flow rate and a second set had issue with hydrogel peeling off.
 
Manufacturer Narrative
The reported event was confirmed - cause unknown.Visual evaluation noted 1 opened large arctic gel leg pad was received.Visual evaluation noted there was separation between the hydrogel and the pad.A potential root cause for this failure could be improper design consideration or material selection.A potential root cause for this failure could be improper design consideration or material selection.The product does not meet specifications.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (arctic gel pads) product ifus were found to be adequate based on past reviews.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.
 
Event Description
It was reported that the arctic sun device was reading low flow when user just initiated therapy.The target temperature was 33c, patient temperature was 36.3c, water temperature was 6.9c and flow rate was fluctuating between 1.7 l/min to 2.2 l/min.Patient was getting a central line and preparing to transfer to intensive care unit (icu).Mss explained to regional nurse to purge pads, disconnected and reconnected it.The four pads were connected appropriately without kinks.The regional nurse stated the flow rate was still fluctuating.Mss asked the regional nurse if they had time to do deep troubleshooting.The user stated they would get another device.Per call back, the nurse stated 2nd arctic sun device was in intensive care unit (icu) and was ready to transport patient.The nurse was going to tag device and send it to biomed for checks.The regional nurse told intensive care (icu) when they connect patient to device if they had low flow, it might be a pad issue.Mss told regional nurse would check with intensive care unit (icu).Mss walked through troubleshooting on second device.The patient temperature was 36.1 c with flow rate around 1.5 l/min to 1.7 l/min.Mss asked regional nurse to disconnect pads one at a time.The user disconnected right thigh pad and flow rate was 1.7 l/min after a few minutes.Left thigh disconnected and the flow rate was 1.0 l/min after a few minutes.Left chest disconnected and the flow rate was 1.0 after a few minutes.Right chest disconnected and the flow rate was 1.0 after a few minutes.Mss recommended regional nurse to change out right thigh pad with a universal pad and to call back if the issue was not resolved and asked regional nurse to save right thigh in case field assurance requested.It was confirmed that the issue was with arctic gel pads not with the arctic sun device.Per additional information received on 01jun2021, nurse stated that the arctic gel pads would be returned.Therapy was completed with a new set of pads and the arctic sun device was not sent to biomed.Per additional information received on 27jul2021, there were two sets of faulty pads.One pad set had an issue with flow rate and a second set had issue with hydrogel peeling off.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL 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 Key12351265
MDR Text Key267619809
Report Number1018233-2021-05069
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Lot NumberNGEQY269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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