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

Model Number 50000000E

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2022

Event Type  malfunction  

Event Description

It was reported that the neonate was cooling on the arctic sun device with 31.21 hours left.The device sounded alert 02 (low flow).The nurse was concerned because the neonate was slightly above the target temperature of 33.5c and the water temperature was still very warm.The nurse stated that the patient temperature was 33.6c, water temperature was 39.8c, flow rate was 0.6l/min, event log showed several alert 02 (low flow) and no other alarms or alerts.The nurse stated that the system diagnostics water control showed flow rate was 0.6l/min, inlet pressure was -7psi, circulation pump command was 28 percent.Mss asked the nurse to look for bends and kinks in the tubing.The nurse found a significant kink in the clear tubing under the blue foam where the tubing adjoins the pad.Nurse adjusted the tubing removing the kink and the fr rose to 1.2l/min.Mss recommended the nurse to make sure the other nurses know to avoid kinking that area of tubing when adjusting the neonate's position.Mss explained that when a patient was at the target temperature the water will not always be cold.Mss explained how the water temperature adjusts every 2 minutes to keep the patient at the target temperature.After the tubing was adjusted, flow rate rose, and the water temperature started to decrease.The nurse stated that water temperature was 37.5c when the call ended.Mss received a second call from nurse at 3:05 am.The nurse had accidentally turned the device off and was anxious about the settings being saved.Mss explained that you just press the continue or resume current patient button and to resume therapy and no settings were lost.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive as no sample was returned.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "operator error".The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review and the device history record could not be reviewed.Correction: g.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 neonate was cooling on the arctic sun device with 31.21 hours left.The device sounded alert 02 (low flow).The nurse was concerned because the neonate was slightly above the target temperature of 33.5c and the water temperature was still very warm.The nurse stated that the patient temperature was 33.6c, water temperature was 39.8c, flow rate was 0.6l/min, event log showed several alert 02 (low flow) and no other alarms or alerts.The nurse stated that the system diagnostics water control showed flow rate was 0.6l/min, inlet pressure was -7psi, circulation pump command was 28 percent.Mss asked the nurse to look for bends and kinks in the tubing.The nurse found a significant kink in the clear tubing under the blue foam where the tubing adjoins the pad.Nurse adjusted the tubing removing the kink and the fr rose to 1.2l/min.Mss recommended the nurse to make sure the other nurses know to avoid kinking that area of tubing when adjusting the neonate's position.Mss explained that when a patient was at the target temperature the water will not always be cold.Mss explained how the water temperature adjusts every 2 minutes to keep the patient at the target temperature.After the tubing was adjusted, flow rate rose, and the water temperature started to decrease.The nurse stated that water temperature was 37.5c when the call ended.Mss received a second call from nurse at 3:05 am.The nurse had accidentally turned the device off and was anxious about the settings being saved.Mss explained that you just press the continue or resume current patient button and to resume therapy and no settings were lost.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: ARTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14363427
• MDR Text Key: 291624941
• Report Number: 1018233-2022-03626
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other