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

Catalog Number UNKNOWN

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Sedation (2368); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2020

Event Type  Injury  

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 the baby was cooling on arctic sun device.The patient's temperature was increasing and the water temperature was decreasing.The nurse was concerned that the water temperature was decreasing.The flow rate was 0.6lpm.The target temperature was 33.5c, patient temperature was 33.9c and the water temperature was 14c.Disconnected, rotated connectors and reconnected the arctic gel pads.The flow rate was 0.9lpm.Baby was in crib.Tubing not twisted or kinked.Discussed causes of heat generation.Doctor stated the baby was "too sedated" so they backed off the morphine.Rectal check reads 32.9c.Suggested confirming esophageal probe placement.Esophageal probe replaced and tip confirmed by x-ray.Probe now reads 33.5c.Explained the patient might not stay at exactly 33.5c and might drift slightly above and below the target temperature.The water temperature would increased and decreased as needed.Baby was taco'ed in and directly on the arctic gel pad.Doctor called back 2am.Patient's temperature was now 33.9c and the water temperature was 10c.They decided to change the arctic gel pad.Morphine increased.Doctor denies any signs of heat generation, but nurse in background stated it appears the baby was shivering.Difficult to assess seizure activity with beside electroencephalogram (eeg).Doctor asked about changing the arctic sun device.Explained that the arctic sun device was functioning properly.Continued to address the heat generation per facility protocol and be diligent with skin checks.Per follow up on (b)(6) 2020, therapy was completed on 2nd arctic sun device.First arctic sun device was sent to biomed but it passed the functional test so the out the device back in service.Therapy was also completed on 2nd set of arctic gel pads.1 set of arctic gel pads was with clinical nurse manager (b)(6).They weined the patient off morphine due to shallow breathing.Also increased morphine later to keep patient temperature low.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to belt temperatures too low after nip roller and the heated section.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.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.

Event Description

It was reported that the baby was cooling on the arctic sun device.The patient temperature was increasing and the water temperature was decreasing.The nurse was concerned that the water temperature was decreasing.The flow rate was  0.6 lpm.The target temperature was 33.5 c the patient temperature was 33.9 c and the water temperature was 14 c.The nurse disconnected rotated the connectors and reconnected the arctic gel pads.The flow rate was 0.9 lpm.The baby was in crib.The tubing was not twisted or kinked.Ms and s discussed the causes of heat generation.The doctor stated the baby was too sedated so they backed off the morphine.The rectal check reads 32.9 c.Ms and s suggested confirming the esophageal probe placement.The esophageal probe replaced and the tip confirmed by x ray.The probe now reads 33.5 c.The nurse explained the patient did not stay at exactly 33.5 c and drift slightly above and below the target temperature.The water temperature would be increased and decreased as needed.The doctor called back.  the patient temperature was 33.9 c and the water temperature was 10 c.They decided to change the arctic gel pad and morphine was increased.The doctor denied any signs of heat generation but the nurse in the background stated it appears the baby was shivering.The nurse difficult to assess the seizure activity with beside electroencephalogram (eeg).The doctor asked about changing the arctic sun device.Ms and s explained that the arctic sun device was functioning properly.The nurse continued to address the heat generation per facility protocol and be diligent with the skin checks.Per follow up via nurse on 29oct2020 the therapy was completed on 2nd arctic sun device.The first arctic sun  device sent to biomed but it passed the functional tests so the device was back in service.The therapy was also completed on the 2nd set of arctic gel pads.First set of arctic gel pads with the clinical nurse manager.They weaned using the patient off morphine due to the shallow breathing.Also increased the morphine later to keep the patient temperature low.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 10838607
• MDR Text Key: 216327875
• Report Number: 1018233-2020-20952
• 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,use
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention