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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PADS Back to Search Results
Catalog Number UNKNOWN
Device Problems Restricted Flow rate (1248); Device Displays Incorrect Message (2591); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd 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 bd.
 
Event Description
It was reported that there was low flow on the arctic sun device.The nurse stated they have been receiving alerts about leaks in the lines after sending patient to computed tomography.Nurse stated that they swapped out pads for a new set of pads, but they were still receiving alerts.Patient was at 34.3c, target temperature was 33c, water temperature was 7.6c, and there was no flow.Event log showed alert 001 and alert 002.Ms&s walked nurse through disconnecting and reconnecting using proper technique.All lines were straight with no kinks or bends noted.They started the therapy and device continued to flash priming and conditioning.There was no flow.The nurse placed device in manual mode at 5c.Temperature 1 was 6.3c, temperature 2 was 6.3c, temperature 3 was 27.7c, temperature 4 was 5.1c, water flow rate was 0, inlet pressure was 0, circulation pump command was 100, mixing pump command was 0, and heater was 0.System hours were 5612 and pump hours were 5112.The circulation pump appeared to have gone out.The nurse noted they have another device they could try.
 
Event Description
It was reported that there was low flow on the arctic sun device.The nurse stated they have been receiving alerts about leaks in the lines after sending patient to computed tomography.Nurse stated that they swapped out pads for a new set of pads, but they were still receiving alerts.Patient was at 34.3c, target temperature was 33c, water temperature was 7.6c, and there was no flow.Event log showed alert 001 and alert 002.Ms&s walked nurse through disconnecting and reconnecting using proper technique.All lines were straight with no kinks or bends noted.They started the therapy and device continued to flash priming and conditioning.There was no flow.The nurse placed device in manual mode at 5c.Temperature 1 was 6.3c, temperature 2 was 6.3c, temperature 3 was 27.7c, temperature 4 was 5.1c, water flow rate was 0, inlet pressure was 0, circulation pump command was 100, mixing pump command was 0, and heater was 0.System hours were 5612 and pump hours were 5112.The circulation pump appeared to have gone out.The nurse noted they have another device they could try.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.Corrections: d4, d10, h3.H11:section a through f - the information provided by bd represents all of the known information at this tim.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.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10543308
MDR Text Key208147948
Report Number1018233-2020-05969
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/16/2020
Supplement Dates Manufacturer Received12/14/2020
Supplement Dates FDA Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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