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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICSUN GEL PADS
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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICSUN GEL PADS Back to Search Results
Catalog Number 317-07
Device Problems Air Leak (1008); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2016
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 when the hypothermia therapy began, the device worked well.The arctic sun was disconnected while a ct scan was performed.When the pads were reconnected, an air-leak error showed and water did not circulate.The hospital staff tried to use the pads with a different machine but they still did not work.The pads were switched out and therapy continued successfully; however, there was a 15 to 30 minute delay to the procedure.
 
Manufacturer Narrative
Received 1 used medium arctic gel pad kit.The visual inspection noted a crack in the connector of the left chest pad.The other connectors were found slightly deformed in the tip of the energy connectors.No other obvious defects were observed.The pads were submitted to the flow rate test with the arctic sun machine model 2000.The pads were connected to the arctic sun machine model 2000 for 10 minutes, see details below: left chest pad: a total of 1.27 l/min m2 of flow rate were registered during the test due to deformed energy connector causing air leakage.Left thigh pad: the flow was never stabilized due to the energy connector was cracked causing air leakage.Right chest pad: a total of 3.98 l/min m2 of flow rate were registered during the test right thigh pad: a total of 4.14 l/min m2 of flow rate were registered during the test.The flow rate of the right thigh pad was never stabilized because the energy connector was damaged (deformed) causing air leakage, the left chest pad gave low flow due to deformed energy connector causing air leakage.The flow rate was found to be acceptable for the other pads.The flow rate for this product must be above 2.4 l/min m2.The reported issue was confirmed with an unknown cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.¿ ¿once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.¿ (b)(4).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 when the hypothermia therapy began, the device worked well.The arctic sun was disconnected while a ct scan was performed.When the pads were reconnected, an air-leak error showed and water did not circulate.The hospital staff tried to use the pads with a different machine but they still did not work.The pads were switched out and therapy continued successfully; however, there was a 15 to 30 minute delay to the procedure.
 
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Brand Name
ARCTICSUN GEL PADS
Type of Device
ARCTICSUN GEL PADS
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX  85621
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX   85621
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6072619
MDR Text Key59342474
Report Number1018233-2016-01532
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Catalogue Number317-07
Device Lot NumberNGZK0519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2015
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) Required Intervention;
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