MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number 5000-01-01

Device Problem Component Misassembled (4004)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd represents all 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 the arctic sun device did not turn on.Per follow up information received on 06jul2022, heater was substituted and send to crawley for chiller repair.There was no patient involvement.Per follow up information received on 14jul2022, the heater was the root cause of the device not powering on.The chiller issue was detected during repair of the heater.Per sample evaluation results received on 26apr2023, it was reported that the root cause of the reported issue was a heater failure.It was confirmed the device did not turn on due to the heater.The chiller was found to be damaged.It was stated that when unit had been inspected and dismantled at palex, quite a few parts were incorrectly wired on wrong sockets on boards and re-plugged incorrectly.It was noted that reservoir was unable to fill up.It was noted that there were issues with the circulation pump, shell, manifold and power module.It was also noted that circulation pump, shell with louvers, manifold assembly, and power module need replaced.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is operator error.The device was evaluated upon receipt.Per crawley, when unit had been inspected and dismantled at palex, quite a few parts were incorrectly wired on wrong sockets on boards and re-plugged incorrectly.Repairs were too costly and the device was scrapped.Dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The instructions for use were found adequate and state the following: "8.5 removing / replacing circuit cards from card cage to access the cards in the card cage, remove the back panel and the outer shell as shown in steps 8.3 and 8.4.Attention: observe electrostatic discharge control procedures when handling circuit cards.A) input / output circuit card 1.Carefully disconnect each of the eight cables connected to the card, releasing each locking tab before pulling.These connections are illustrated in fig.8-15.2.Clip cable ties with wire cutters as needed.3.When re-connecting the connections after repair, check labels on j6 and j4 connectors to ensure correct connections.4.Remove the allen head screw on the right of the i/o circuit card face plate.5.Slide a screwdriver beneath the i/o circuit card to gently pry it away from its base.6.Carefully pull the circuit card outward to release it from the slots it sits in.7.When replacing the circuit card, ensure that the card fits into the retaining grooves on either side of the card cage.8.After replacing the i/o circuit card, perform a calibration (see chapter 9).B) isolation circuit card 1.Remove the allen head screw on the right of the isolation circuit card face plate.2.Slide a screwdriver beneath the isolation circuit card to gently pry it away from its base.3.Carefully slide the circuit card out of the card cage until the card protrudes approximately one inch to expose the cable connecting this card to the top of the card cage.4.Remove the screws holding the cable that connects this card to the top of the card cage.5.Carefully pull the circuit card outward to release it from the grooves it sits in.6.When replacing the circuit card, ensure that the card fits into the retaining slots on either side of the card cage.7.After replacing the isolation circuit card, perform a calibration (see chapter 9).C) processor circuit card 1.Remove the allen head screw on the right of the processor circuit card face plate.2.Slide a screwdriver beneath the processor circuit card to gently pry it away from its base.3.Carefully pull the circuit card outward to release it from the grooves.4.When replacing the circuit card, ensure that the card fits into the retaining slots on either side of the card cage.5.After replacing the processor circuit card, perform a calibration (see chapter 9).D) power circuit card 1.Remove the allen head screw on the right of the power circuit card face plate.2.Slide a screwdriver beneath the power circuit card to gently pry it away from its base.3.Carefully slide the circuit card out of the card cage until the card protrudes approximately one inch (3 cm) to expose the three connections.4.Carefully disconnect each of the three connections, releasing each locking tab before pulling.(when replacing these connections, tuck the wires into place against the foam.) 5.When replacing the circuit card, ensure that the card fits into the retaining slots on either side of the card cage." the information provided by bd represents all 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 the arctic sun device did not turn on.Per follow up information received on 06jul2022, heater was substituted and send to crawley for chiller repair.There was no patient involvement.Per follow up information received on 14jul2022, the heater was the root cause of the device not powering on.The chiller issue was detected during repair of the heater.Per sample evaluation results received on 26apr2023, it was reported that the root cause of the reported issue was a heater failure.It was confirmed the device did not turn on due to the heater.The chiller was found to be damaged.It was stated that when unit had been inspected and dismantled at palex, quite a few parts were incorrectly wired on wrong sockets on boards and re-plugged incorrectly.It was noted that reservoir was unable to fill up.It was noted that there were issues with the circulation pump, shell, manifold and power module.It was also noted that circulation pump, shell with louvers, manifold assembly, and power module need replaced.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16945416
• MDR Text Key: 315371652
• Report Number: 1018233-2023-03489
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161602
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other