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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS Back to Search Results
Catalog Number 317-09
Device Problems Break (1069); Restricted Flow rate (1248); Device Displays Incorrect Message (2591); No Flow (2991)
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. The device was not returned.
 
Event Description
It was reported that the flow rate was 0 l/min and the device stopped once the pads were reconnected when the patient returned from ct. The device read alert 01 (patient line opened). There was four pads in place with good coverage, the target temperature was 37c and the patients temperature 37c. With the pads attached the flow rate was 0 l/min, the inlet pressure was -0. 4 psi, and the circulation pump command was running at 100%. The pads and fluid delivery line were examined for damages and none were noted. The pads were disconnected and reconnected holding only the blue foam tubing. Therapy was restarted and the flow rate was still sub-optimal at 1 l/min and then dropped to 0 l/min. The fluid delivery line (fdl) was disconnected and the nurse stated there was strong suction. The fdl was attached and the flow remained at 0 l/min. The pads were disconnected and the nurse noted that the left chest pad appeared to be broken with a ragged edge on the clear connectors. The nurse stated that the patient required therapy for a longer period of time and would just exchange all the pads. Ms&s called nurse back an hour later and it was noted that only two pads were exchanged and the flow was still 0 l/min. It was recommended that the other two pads be exchanged. Ms&s followed up again and the nurse connected a new set of pads and the flow rate was still 0 l/min. It was recommended the device was exchanged. Per additional information received, the patient was in normothermia therapy and the patient was maintaining target temperature.
 
Event Description
It was reported that the flow rate was 0 l/min and the device stopped once the pads were reconnected when the patient returned from ct. The device read alert 01 (patient line opened). There was four pads in place with good coverage, the target temperature was 37c and the patients temperature 37c. With the pads attached the flow rate was 0 l/min, the inlet pressure was -0. 4 psi, and the circulation pump command was running at 100%. The pads and fluid delivery line were examined for damages and none were noted. The pads were disconnected and reconnected holding only the blue foam tubing. Therapy was restarted and the flow rate was still sub-optimal at 1 l/min and then dropped to 0 l/min. The fluid delivery line (fdl) was disconnected and the nurse stated there was strong suction. The fdl was attached and the flow remained at 0 l/min. The pads were disconnected and the nurse noted that the left chest pad appeared to be broken with a ragged edge on the clear connectors. The nurse stated that the patient required therapy for a longer period of time and would just exchange all the pads. Ms&s called nurse back an hour later and it was noted that only two pads were exchanged and the flow was still 0 l/min. It was recommended that the other two pads be exchanged. Ms&s followed up again and the nurse connected a new set of pads and the flow rate was still 0 l/min. It was recommended the device was exchanged. Per additional information received, the patient was in normothermia therapy and the patient was maintaining target temperature.
 
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: ¿indications for use the arctic sun® temperature management system. Is intended for monitoring and controlling patient temperature in adult and pediatric patients of all ages. Contraindications. There are no known contraindications for the use of a thermoregulatory system. Do not place arcticgel¿ pads on skin that has signs of ulcerations, burns, hives or rash. ¿ while there are no known allergies to hydrogel materials, caution should be exercised with any patient with a history of skin allergies or sensitivities. Warning do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient. Cautions federal law restricts this device to sale by or on the order of a physician. This product is to be used by or under the supervision of trained, qualified medical personnel. The clinician is responsible for determining the appropriateness of use of this device and the usersettable parameters, including water temperature, for each patient. For small patients (
=
30 kg) it is recommended to use the following settings: water temperature high limit
=
40°c (104°f); water temperature low limit
=
10°c (50°f); control strategy
=
2. It is recommended to use the patient temperature high and patient temperature low alert settings. Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold. Patients at risk include those with poor tissue perfusion or poor skin integrity due to edema, diabetes, peripheral vascular disease, poor nutritional status or steroid or high dose vasopressor therapy. If accessible, examine the patient¿s skin under the arcticgel¿ pads often; especially those patients at higher risk of skin injury. ¿ skin injury may occur as a cumulative result of pressure, time and temperature. Possible skin injuries include bruising, tearing, skin ulcerations, blistering, and necrosis. Do not place bean bags or other firm positioning devices under the arcticgel¿ pads. Do not place any positioning devices under the pad manifolds or patient lines. Do not allow urine, antibacterial solutions or other agents to pool underneath the arcticgel¿ pads. Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion. Replace pads immediately if these fluids come into contact with the hydrogel. Do not place arcticgel¿ pads directly over an electrosurgical grounding pad. The combination of heat sources may result in skin burns. Carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use. Aggressive removal or removal of cold pads from the patient¿s skin may result in skin tears. The arcticgel¿ pads are non-sterile for single patient use only. Do not place pads in the sterile field. If used in a sterile environment, pads should be placed according to the physician¿s directions, either prior to the sterile preparation or sterile draping. Do not reprocess or sterilize. Use pads immediately after opening. Do not store pads in opened pouch. Do not allow circulating water to contaminate the sterile field when lines are disconnected. The arcticgel¿ pads should not be punctured with sharp objects. Punctures will result in air entering the fluid pathway and may reduce performance. If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury. The arcticgel¿ pads are only for use with an arctic sun® temperature management system. The water content of the hydrogel affects the pad¿s".
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7641042
MDR Text Key112717053
Report Number1018233-2018-02436
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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