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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS Back to Search Results
Catalog Number 317-09
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
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 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.
Event Description
It was reported that the patient was cooling on the device 5755 since 2:55 pm. The nurse stated that the patient weighed (b)(6) and four large pads were in place when the patient arrived at (b)(6) hospital. The screen showed an alarm for ¿low air leak¿. The patient temperature was 36. 3c, the target temperature was 33c, the water temperature was 6. 5c, and the flow rate was 0. 8 l/min. Per troubleshooting, the event log showed an alert 01 (patient open line) and an alert 02 (low air leak). The nurse was advised on how to disconnect and reconnect the pads using the proper technique. The flow rate was 0. 2 l/min. The nurse declined troubleshooting the pads and alternatively replaced the device. It was discussed that the pads be emptied into the first device before switching to the new device. She was also advised that if there was a suboptimal flow rate displayed, it was an issue with the pads. The nurse was called back 30 min later and she reported that the issue was with the pads. She replaced the pads and the flow rate stabilized at 2. 7 l/min.
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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
amy gravley
8195 industrial blvd
covington, GA 30014
MDR Report Key7434602
MDR Text Key105930331
Report Number1018233-2018-01221
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number317-09
Device Lot NumberNGCN1317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial