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

Device Problem Fracture (1260)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: 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 nurse had a patient on the arctic sun device that just returned from the catheterization laboratory.When nurse reconnected the pads and resumed therapy, the device primes and then alarms low flow, air in the line.Mis informed nurse to pause therapy and empty pads.Mis had nurse to disconnect and explained to reconnect the pads holding the blue tubing and not the clear connectors.While connecting pads, nurse noticed one of the plastic connectors was cracked and had a chip in it.Also informed nurse if they have a universal pad, they could swap it out with the one damaged pad.Nurse stated that they only have the set of pads and nurse would swap out the entire set.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "received connectors damaged by supplier." the device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: 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 nurse had a patient on the arctic sun device that just returned from the catheterization laboratory.When nurse reconnected the pads and resumed therapy, the device primes and then alarms low flow, air in the line.Mis informed nurse to pause therapy and empty pads.Mis had nurse to disconnect and explained to reconnect the pads holding the blue tubing and not the clear connectors.While connecting pads, nurse noticed one of the plastic connectors was cracked and had a chip in it.Also informed nurse if they have a universal pad, they could swap it out with the one damaged pad.Nurse stated that they only have the set of pads and nurse would swap out the entire set.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: ARCTICGEL 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16911101
• MDR Text Key: 314997233
• Report Number: 1018233-2023-03328
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/22/2023
• 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