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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS NEONATAL PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS NEONATAL PAD Back to Search Results
Catalog Number 318-02
Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964); Temperature Problem (3022); Non Reproducible Results (4029)
Patient Problems Bradycardia (1751); Death (1802); Encephalopathy (1833); Sepsis (2067); No Consequences Or Impact To Patient (2199); Respiratory Failure (2484)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported on 08may2020 that the arctic sun device, sn (b)(4), with neonatal pad lot number, ngen1815, was displaying an alarm 113; reduced water temperature control and an alert 02; low flow. This occurred during the cooling phase of therapy for a (b)(6)- day old neonate with hypoxic ischemic encephalopathy. The nurse changed the neonatal pad to a pad from lot number, ngdz2984, but the issues persisted. The nurse then phoned ms&s for troubleshooting assistance. The target temperature was 33. 5 c. The patient¿s temperature was 32. 6 c. The water temperature was 28. 9 c. The flow rate was between 0. 3-0. 4l/min. The inlet pressure was -4 psi. The event log confirmed the alarm 113 and the alert 02. The pads were disconnected and reconnected using proper technique. The patient¿s temperature decreased to 32. 4 c. The water temperature was 29c. The flow rate was 0. 4 l/min. The inlet pressure was -7psi. The water level showed 2 bars. The nurse was advised to switch the device out and send it to biomed and save the pads for return. Per additional information received by the fa specialist on 09may2020, the nurse continued therapy with a different device, sn (b)(4), but used the same neonatal pad with lot number, ngdz2984. The second device gave an alarm 113 on (b)(6) 2020 and the pad was then changed. Additional information was received on 01jun2020 via a medwatch that both devices were evaluated by the facility biomed department and the failures were unable to be duplicated. Both devices reportedly passed functional tests and were placed back into service. The risk manager reported on 02jun2020 during a follow-up phone call that the neonate was able to reach target temperature on the second device, without issue, after the pad was changed out. The risk manager also reported that the newborn expired on (b)(6) 2020 during the rewarming phase of therapy and stated the death was not device related. The cause of death documented in the medical record was respiratory failure secondary to bacterial sepsis and ischemic encephalopathy. The risk manager reported other medical diagnoses included neonatal bradycardia and ventilator dependency.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
Type of DeviceNEONATAL PAD
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 Key10116099
MDR Text Key194307286
Report Number1018233-2020-03537
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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