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

Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964); Temperature Problem (3022)

Patient Problems Fever (1858); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that there was low flow.Patient started rewarming last night.The nurse stated that the device showed normothermia and the patient was above the 37c target.Patient was 38.1c, and flow rate was 1.1l/min.There were 4 pads in place with good coverage.Ms&s had the nurse enable manual control and set the water to 10 c for 30 minutes.Thermistor 1 and thermistor 2 were 38.1c, and the water temperature never dropped.Thermistor 4 chiller was 2.8c.Pump hours were 3064 and system hours were 3464.The event log showed an alert 113.Ms&s recommended she change out the device and label that one with alert 113/mixing pump and send to the biomed.Ms&s stated if the flow rate did not rise after connecting to a different device they would need to change the pads.Per additional information on 2/11/2020, the original arctic sun device was swapped for device dyyiy007, and the nurse stated the patient was not heating on the arctic sun device.The nurse reported that her patient cooled and rewarmed.They switched to normothermia with a target of 37.2c.The patient was below target at 36.5c.Water was 30.1c, and flow rate was 1l/min.The nurse reported the patient ran a fever.Ms&s informed her there was no need to change the therapy settings.The device was set to rewarm at 0.3c/hour.Ms&s explained the rewarm setting and why the water would not get really hot, and it would take about 2 hours to get the patient up to the 37c target.Ms&s informed the nurse that the patient's temperature could be slightly below or above target and still be considered at target.36.5c in normothermia was not considered significant.The nurse enabled manual control and set water temperature to 38c, and the water started to rewarm very slowly.Water reservoir was 5.Pump hours were 3384 and system hours were 3839.With pads attached the flow rate was 1l/min, inlet pressure was 7.3psi, and circulation pump was 35%.The nurse disconnected and reconnected the pads, and flow stabilized at 1.1l/min.There were no bends or kinks in the tubing found.Ms&s walked her through draining 500 mls of water from the right drain port, and water temperature rose to 38c.The nurse disabled manual control.Ms&s informed the nurse that the flow rate was low at 1.1l/min, and yesterday she told the nurse to change the pads if the patient temperature was not being controlled.The nurse stated that the patient would be kept at 37c for several days so she wanted to change the pads.The nurse decided to stop therapy and go back to hypothermia rewarming settings.Ms&s walked her through programming the device to rewarm from 37c to 37c.Water temperature quickly rose to 37c.Ms&s recommended they determine how long the patient would be on therapy and if they wanted to change the pads.A flow rate less than 1.7l/min would be considered inadequate.Ms&s informed the nurse that the device would maintain the patient at 37c until the device was turned off.

Event Description

It was reported that there was low flow.Patient started rewarming last night.The nurse stated that the device showed normothermia and the patient was above the 37c target.Patient was 38.1c, and flow rate was 1.1l/min.There were 4 pads in place with good coverage.Ms&s had the nurse enable manual control and set the water to 10 c for 30 minutes.Thermistor 1 and thermistor 2 were 38.1c, and the water temperature never dropped.Thermistor 4 chiller was 2.8c.Pump hours were 3064 and system hours were 3464.The event log showed an alert 113.Ms&s recommended she change out the device and label that one with alert 113/mixing pump and send to the biomed.Ms&s stated if the flow rate did not rise after connecting to a different device they would need to change the pads.Per additional information on 2/11/2020, the original arctic sun device was swapped for device dyyiy007, and the nurse stated the patient was not heating on the arctic sun device.The nurse reported that her patient cooled and rewarmed.They switched to nomothermia with a target of 37.2c.The patient was below target at 36.5c.Water was 30.1c, and flow rate was 1l/min.The nurse reported the patient ran a fever.Ms&s informed her there was no need to change the therapy settings.The device was set to rewarm at 0.3c/hour.Ms&s explained the rewarm setting and why the water would not get really hot, and it would take about 2 hours to get the patient up to the 37c target.Ms&s informed the nurse that the patient's temperature could be slightly below or above target and still be considered at target.36.5c in normothermia was not considered significant.The nurse enabled manual control and set water temperature to 38c, and the water started to rewarm very slowly.Water reservoir was 5.Pump hours were 3384 and system hours were 3839.With pads attached the flow rate was 1l/min, inlet pressure was 7.3psi, and circulation pump was 35%.The nurse disconnected and reconnected the pads, and flow stabilized at 1.1l/min.There were no bends or kinks in the tubing found.Ms&s walked her through draining 500 mls of water from the right drain port, and water temperature rose to 38c.The nurse disabled manual control.Ms&s informed the nurse that the flow rate was low at 1.1l/min, and yesterday she told the nurse to change the pads if the patient temperature was not being controlled.The nurse stated that the patient would be kept at 37c for several days so she wanted to change the pads.The nurse decided to stop therapy and go back to hypothermia rewarming settings.Ms&s walked her through programming the device to rewarm from 37c to 37c.Water temperature quickly rose to 37c.Ms&s recommended they determine how long the patient would be on therapy and if they wanted to change the pads.A flow rate less than 1.7l/min would be considered inadequate.Ms&s informed the nurse that the device would maintain the patient at 37c until the device was turned off.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿incorrect water flow¿.A potential root cause for this failure could be " inadequate channel design".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required.The product code for this z300-unknown articgels pads product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z300-unknown articgels pads product labeling is found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9775861
• MDR Text Key: 185257093
• Report Number: 1018233-2020-01455
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1