MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS

Catalog Number 318-02

Device Problems Break (1069); Restricted Flow rate (1248); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

Event Date 11/14/2019

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 while a neonate patient was cooling on the arctic sun device, the device alerted low flow with the flow rate noted at 0.4 l/min.The complainant advised that the patient was at the target temperature of 33.5c and the water temperature was 28.8c.Per troubleshooting with ms&s, with the pad attached, the flow rate was 0.4 l/min, the ip was -7.0, and the circulation pump was operating at 100%.The complainant confirmed that there were no bends or kinks in the tubing.The pad was disconnected and reconnected, but the flow rate remained sub-optimal at 0.5 l/min.Ms&s advised to change out the pad as no other devices were available.With the new pad, the flow rate was 1.4 l/min.An additional call was made to ms&s on (b)(6) 2019 to determine if the pad was safe to use during an mri.The complainant then advised that the neonate was sent to ct the previous day and as a result, the pad was damaged, and the flow rate kept decreasing below 0.5 l/min.The heater was unable to function at a capacity of 0.5l/min and below.As a result, the patients temperature was erratic.An erratic temperature alert appeared on the screen of the arctic sun device, and the water temperature would fluctuate with flow rate.When the flow rate would increase above 1.1l/min, the water temperature quickly rose to 40.3c.When the flow rate dropped below 0.5l/min, the water temperature would drop.Despite replacing the pad, the issues with the flow rate was not resolved.It was unknown if therapy was completed.The device was sent to biomed for evaluation.During a follow-up phone call on (b)(6) 2019, nurse mary stated that the patient expired on (b)(6) 2019.A clinical follow up call was placed on (b)(6) 2019 by a bd clinical risk specialist.Nurse mary stated the neonate was male and diagnosed with encephalopathy.She reported the patient expired due to his condition.Nurse mary declined to provide any additional information.The cause of death and additional patient history was unknown.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be '2.1 device is damaged¿ with a potential root cause of '2.1.1 improper consideration of end user requirements shipping or handling caused damage to device.¿ the lot number is unknown; therefore, the device history record could not be reviewed.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.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.The device was not returned.

Event Description

It was reported that while a neonate patient was cooling on the arctic sun device, the device alerted low flow with the flow rate noted at 0.4 l/min.The complainant advised that the patient was at the target temperature of 33.5c and the water temperature was 28.8c.Per troubleshooting with ms&s, with the pad attached, the flow rate was 0.4 l/min, the ip was -7.0, and the circulation pump was operating at 100%.The complainant confirmed that there were no bends or kinks in the tubing.The pad was disconnected and reconnected, but the flow rate remained sub-optimal at 0.5 l/min.(b)(6) advised to change out the pad as no other devices were available.With the new pad, the flow rate was 1.4 l/min.An additional call was made to (b)(6) on (b)(6) 2019 to determine if the pad was safe to use during an mri.The complainant then advised that the neonate was sent to ct the previous day and as a result, the pad was damaged, and the flow rate kept decreasing below 0.5 l/min.The heater was unable to function at a capacity of 0.5l/min and below.As a result, the patient's temperature was erratic.An erratic temperature alert appeared on the screen of the arctic sun device, and the water temperature would fluctuate with flow rate.When the flow rate would increase above 1.1l/min, the water temperature quickly rose to 40.3c.When the flow rate dropped below 0.5l/min, the water temperature would drop.Despite replacing the pad, the issues with the flow rate was not resolved.It was unknown if therapy was completed.The device was sent to biomed for evaluation.During a follow-up phone call on (b)(6) 2019, nurse (b)(6) stated that the patient expired on (b)(6) 2019.A clinical follow up call was placed on (b)(6) 2019 by a bd clinical risk specialist.Nurse (b)(6) stated the neonate was male and diagnosed with encephalopathy.She reported the patient expired due to his condition.Nurse (b)(6) declined to provide any additional information.The cause of death and additional patient history was unknown.

Manufacturer Narrative

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

Event Description

It was reported that while a neonate patient was cooling on the arctic sun device, the device alerted low flow with the flow rate noted at 0.4 l/min.The complainant advised that the patient was at the target temperature of 33.5c and the water temperature was 28.8c.Per troubleshooting with (b)(6), with the pad attached, the flow rate was 0.4 l/min, the ip was -7.0, and the circulation pump was operating at 100%.The complainant confirmed that there were no bends or kinks in the tubing.The pad was disconnected and reconnected, but the flow rate remained sub-optimal at 0.5 l/min.(b)(6) advised to change out the pad as no other devices were available.With the new pad, the flow rate was 1.4 l/min.An additional call was made to (b)(6) on (b)(6) 2019 to determine if the pad was safe to use during an mri.The complainant then advised that the neonate was sent to ct the previous day and as a result, the pad was damaged, and the flow rate kept decreasing below 0.5 l/min.The heater was unable to function at a capacity of 0.5l/min and below.As a result, the patient's temperature was erratic.An erratic temperature alert appeared on the screen of the arctic sun device, and the water temperature would fluctuate with flow rate.When the flow rate would increase above 1.1l/min, the water temperature quickly rose to 40.3c.When the flow rate dropped below 0.5l/min, the water temperature would drop.Despite replacing the pad, the issues with the flow rate was not resolved.It was unknown if therapy was completed.The device was sent to biomed for evaluation.During a follow-up phone call on (b)(6) 2019, nurse (b)(6) stated that the patient expired on (b)(6) 2019.A clinical follow up call was placed on (b)(6) 2019 by a bd clinical risk specialist.Nurse (b)(6) stated the neonate was male and diagnosed with encephalopathy.She reported the patient expired due to his condition.Nurse (b)(6) declined to provide any additional information.The cause of death and additional patient history was unknown.

Manufacturer Narrative

The reported event was confirmed.The device did not met specifications.The product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (no original packaging present), neonatal arctic gel pad kit present.One neonatal pad was returned.Visual inspection of the pad surface noted no visible defects such as cuts or tears in the foam.Visual inspection of the clear connectors noted no visible chips or deformities at the ends of all connectors.Visual inspection of the tubing for all the pads noted no kinks.The original liner was intact on the pad.According the test method, the flow rate was found to be acceptable for the returned pad.(acceptable range > 2.4 l/min.M2).However, a low flow - air leak message was noted for the pad, which is out of specification.No hydrogel peeled off any pad when separated from the liner.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿3.2.3 use of punctured pads or pad lines." corrections: additional event information.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.

Event Description

It was reported that while a neonate patient was cooling on the arctic sun device, the device alerted low flow with the flow rate noted at 0.4 l/min.The complainant advised that the patient was at the target temperature of 33.5c and the water temperature was 28.8c.Per troubleshooting with (b)(6), with the pad attached, the flow rate was 0.4 l/min, the ip was -7.0, and the circulation pump was operating at 100%.The complainant confirmed that there were no bends or kinks in the tubing.The pad was disconnected and reconnected, but the flow rate remained sub-optimal at 0.5 l/min.(b)(6) advised to change out the pad as no other devices were available.With the new pad, the flow rate was 1.4 l/min.An additional call was made to (b)(6) on (b)(6) 2019 to determine if the pad was safe to use during an mri.The complainant then advised that the neonate was sent to ct the previous day and as a result, the pad was damaged, and the flow rate kept decreasing below 0.5 l/min.The heater was unable to function at a capacity of 0.5l/min and below.As a result, the patient's temperature was erratic.An erratic temperature alert appeared on the screen of the arctic sun device, and the water temperature would fluctuate with flow rate.When the flow rate would increase above 1.1l/min, the water temperature quickly rose to 40.3c.When the flow rate dropped below 0.5l/min, the water temperature would drop.Despite replacing the pad, the issues with the flow rate was not resolved.It was unknown if therapy was completed.The device was sent to biomed for evaluation.During a follow-up phone call on (b)(6) 2019, nurse (b)(6) stated that the patient expired on (b)(6) 2019.A clinical follow up call was placed on (b)(6) 2019 by a bd clinical risk specialist.Nurse (b)(6) stated the neonate was male and diagnosed with encephalopathy.She reported the patient expired due to his condition.Nurse (b)(6) declined to provide any additional information.The cause of death and additional patient history was unknown.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9417112
• MDR Text Key: 176027266
• Report Number: 1018233-2019-07743
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 318-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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