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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 Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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 there was low flow on the arctic sun device.Therapy was initiated in the emergency room.They transported the patient up to the icu with the arctic gel pads.The patient was being treated on arctic sun device but were getting low flow.The user had already changed a arctic gel pad on the right side thinking it was the cause but the flow was still low.The flow rate was 0.6lpm, the inlet pressure was -2.6psi, the circulation pump was 100%, the pump hours were 2434 and the system hours were 2868.Ms&s suggested changing back to the emergency room device (dycry511) as flow was good on the initial device.The flow rate was 1.5lpm, the inlet pressure was -3.5psi, the circulation pump was 100%, the pump hours were 1193 and the system hours were 1044.Ms&s placed arctic sun device in manual mode with only the fluid delivery line attached.The flow rate was 1.9lpm, the inlet pressure was -6.8psi and the circulation pump was 50%.They attached arctic gel pads one at a time.The diagnostic was as follow: right chest (0.8lpm, -7.3psi with circulation pump command as 31%), right thigh (1.5lpm, -7.2psi with circulation pump command as 49%), left chest (1.6lpm, -7.1psi with circulation pump command as 26%), left thigh (1.4lsp, -4.1psi with circulation pump command as 100%).Ms&s asked to replace the left thigh pad with a universal pad or with the thigh pad from the set previously opened.Patient's temperature was originally 32c and was now up to 33c.Target temperature was 35c, the water temperature was 40c and the flow was 1lpm.Ms&s asked nurse to add a arctic gel pad to the exposed abdomen and to the left thigh if not already added.Explained that the flow should be above he 1.7 lpm and asked to call back if flow should above 1.7 lpm after these measures have been taken.
 
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.H11:section a through f - 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.H3 other text : the device was not returned.
 
Event Description
It was reported that there was low flow on the arctic sun device.Therapy was initiated in the emergency room.They transported the patient up to the icu with the arctic gel pads.The patient was being treated on arctic sun device but were getting low flow.The user had already changed a arctic gel pad on the right side thinking it was the cause but the flow was still low.The flow rate was 0.6lpm, the inlet pressure was -2.6psi, the circulation pump was 100%, the pump hours were 2434 and the system hours were 2868.Ms&s suggested changing back to the emergency room device (dycry511) as flow was good on the initial device.The flow rate was 1.5lpm, the inlet pressure was -3.5psi, the circulation pump was 100%, the pump hours were 1193 and the system hours were 1044.Ms&s placed arctic sun device in manual mode with only the fluid delivery line attached.The flow rate was 1.9lpm, the inlet pressure was -6.8psi and the circulation pump was 50%.They attached arctic gel pads one at a time.The diagnostic was as follow: right chest (0.8lpm, -7.3psi with circulation pump command as 31%), right thigh (1.5lpm, -7.2psi with circulation pump command as 49%), left chest (1.6lpm, -7.1psi with circulation pump command as 26%), left thigh (1.4lsp, -4.1psi with circulation pump command as 100%).Ms&s asked to replace the left thigh pad with a universal pad or with the thigh pad from the set previously opened.Patient's temperature was originally 32c and was now up to 33c.Target temperature was 35c, the water temperature was 40c and the flow was 1lpm.Ms&s asked nurse to add a arctic gel pad to the exposed abdomen and to the left thigh if not already added.Explained that the flow should be above he 1.7 lpm and asked to call back if flow should above 1.7 lpm after these measures have been taken.
 
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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 Key10560104
MDR Text Key221009651
Report Number1018233-2020-06086
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 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
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
Date Manufacturer Received12/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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