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

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.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTIC 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 Key: 6211201
• MDR Text Key: 63475991
• Report Number: 1018233-2016-01871
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• 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 Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 317-00
• Device Lot Number: NGAT1428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention