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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTIC SUN SUN GEL PAD UNIVERSAL

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTIC SUN SUN GEL PAD UNIVERSAL Back to Search Results
Catalog Number 317-00
Device Problems Kinked (1339); Loss of Power (1475); Output below Specifications (3004)
Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Alteration In Body Temperature (2682)
Event Date 12/03/2016
Event Type  Injury  
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 device produced low flow, reading as low as 0. 3lpm. As a result, the heater on the arctic sun device powered off, and the temperature of the neonatal patient dropped below 31°c. Subsequently, because of low temperature, the patient experienced abnormal blood coagulation, and became hemorrhagic. Upon inspection of the device, the pad's tubing appeared kinked; however, when straightened, there was no change in the flow. It was later reported that therapy was interrupted in order to replace the pad with a new universal pad, and therapy was completed.
 
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 device produced low flow, reading as low as 0. 3lpm. As a result, the heater on the arctic sun device powered off, and the temperature of the neonatal patient dropped below 31°c. Subsequently, because of low temperature, the patient experienced abnormal blood coagulation, and became hemorrhagic. Upon inspection of the device, the pad's tubing appeared kinked; however, when straightened, there was no change in the flow. It was later reported that therapy was interrupted in order to replace the pad with a new universal pad, and therapy was completed.
 
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. 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 device produced low flow, reading as low as 0. 3lpm. As a result, the heater on the arctic sun device powered off, and the temperature of the neonatal patient dropped below 31°c. Subsequently, because of low temperature, the patient experienced abnormal blood coagulation, and became hemorrhagic. Upon inspection of the device, the pad's tubing appeared kinked; however, when straightened, there was no change in the flow. It was later reported that therapy was interrupted in order to replace the pad with a new universal pad, and therapy was completed.
 
Manufacturer Narrative
Received 1 used universal pad without original packaging. During the visual evaluation, the pad was reviewed and found to have the trim pattern performed correctly, the plastic tubes were found completely assembled covering the total of clamping rings on the plastic connector and manifold connector. The foam was found free of any damages, tears or perforations, the seal between manifold connector and the pad was found completely sealed, and the energy connector was found free of any damages. The pad presented sealing pattern without any obvious damage. The short tube was noted kinked near the connector manifold connection. Per the functional evaluation, the pad was submitted to the flow rate test with the arctic sun machine model 2000. The pad was connected to the arctic sun machine model 2000 and the kinked tubing was straightened. After 10 minutes, the flow rate was documented, see details below: universal pad: a total of 4. 63 l/min m2 of flow rate were registered during the test. Other flow rate test was performed with the pad connected to the arctic sun machine model 2000 with the tubing kinked and after 10 minutes, the flow rate was documented, see details below: universal pad: no flow was noted. According to the test method, the flow rate was found to be unacceptable when the tubing was kinked; however, when the tubing was straightened, the flow rate was found acceptable. The flow rate for this product must be above 2. 4 l/min m2. The reported event 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: ¿6. 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 the device produced low flow, reading as low as 0. 3lpm. As a result, the heater on the arctic sun device powered off, and the temperature of the neonatal patient dropped below 31°c. Subsequently, because of low temperature, the patient experienced abnormal blood coagulation, and became hemorrhagic. Upon inspection of the device, the pad's tubing appeared kinked; however, when straightened, there was no change in the flow. It was later reported that therapy was interrupted in order to replace the pad with a new universal pad, and therapy was completed.
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTIC SUN SUN GEL PAD UNIVERSAL
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 Key6211201
MDR Text Key63475991
Report Number1018233-2016-01871
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 02/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue Number317-00
Device Lot NumberNGAT1428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2016 Patient Sequence Number: 1
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