MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS

Catalog Number 317-07-02

Device Problems Air Leak (1008); Restricted Flow rate (1248); Cut In Material (2454); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after initiating therapy, the device (s/n (b)(4)) displayed low air leak/low flow alarms, at which the device was switched to a new device (s/n (b)(4)).The flow rate was 0.0 l/min.Per troubleshooting, the pads were disconnected and reconnected using proper technique with no improvement in the flow rate.The fluid delivery line was removed and diagnostics were ran.The pads were then reconnected one by one and there were no signs of flow at the connection sites.It was suggested that the pads be replaced.A call was made 30 minutes later with new pads and the flow rate was still 0.0 l/min.Both set of pads that were used had a lot number of ngby3146.It was recommended that a new set of pads with a different lot number be used.A follow up call was made 30 minutes later, the nurse was unable to switch the pads at that time.Twenty minutes later, the nurse stated that the second set of pads were still getting a sub-optimal flow rate.It was advised that a different device be used; however, it was noted that they only had two devices.The device was switched and there was no improvement to the flow rate.Diagnostics were ran, the pads were reconnected one by one and the flow returned to an optimal range between 2.4-2.6 l/min.The device was switched back to automatic mode and the flow rate was sub-optimal at 1.5 l/min.The nurse heard air noises at the connection site.The pad was moved to another port and the noise went away.The flow rate was 2.6 l/min, but dropped to 1.7 l/min.Per additional information, it was stated that the second set of pads where switched out for a third set of pads and the flow rate increased to an optimal level and no further issues were noted.Therapy was continued with no further issues.Per biomed, one set of pads were obtained and tested.System diagnostic were reviewed and everything was within specification (the flow rate was 1.6 lpm, the inlet pressure was -7.1 psi, and the circulation pump was working at 48%).Reservoir level was 5.The pad was connected one at a time.When chest pad was connected, the flow rate was 1.3 lpm, the inlet pressure was -6.9 lpm, and the circulation pump was working at 60%.When a thigh pad was connected, leaking was noted.The biomed confirmed that both thigh pads had cuts in the clear tubing under the foam.The cuts were under the foam and the foam was intact.The chest pads appeared intact.The pads would be returned to 2nd floor icu.

Manufacturer Narrative

The reported issue was unconfirmed.The pads were inspected and found to have the trim pattern correctly performed.The plastic tubes were found completely assembled, covering the total of clamping rings on the plastic connector and manifold connector.The foams were found free of damages, tears, and perforations.The seal between the manifold connector and pad was found completely sealed, the connectors were found free of damages, and the pads were noted with sealing presence.No manufacturing issues related were noted during the visual evaluation of the pad returned.According to the test method the flow rate was found to be acceptable on all the returned pads.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a fullpad kit.¿ correction: additional information.

Event Description

It was reported that after initiating therapy, the device (s/n (b)(4) ) displayed low air leak/low flow alarms, at which the device was switched to a new device (s/n (b)(4) ).The flow rate was 0.0 l/min.Per troubleshooting, the pads were disconnected and reconnected using proper technique with no improvement in the flow rate.The fluid delivery line was removed and diagnostics were ran.The pads were then reconnected one by one and there were no signs of flow at the connection sites.It was suggested that the pads be replaced.A call was made 30 minutes later with new pads and the flow rate was still 0.0 l/min.Both set of pads that were used had a lot number of ngby3146.It was recommended that a new set of pads with a different lot number be used.A follow up call was made 30 minutes later, the nurse was unable to switch the pads at that time.Twenty minutes later, the nurse stated that the second set of pads were still getting a sub-optimal flow rate.It was advised that a different device be used; however, it was noted that they only had two devices.The device was switched and there was no improvement to the flow rate.Diagnostics were ran, the pads were reconnected one by one and the flow returned to an optimal range between 2.4-2.6 l/min.The device was switched back to automatic mode and the flow rate was sub-optimal at 1.5 l/min.The nurse heard air noises at the connection site.The pad was moved to another port and the noise went away.The flow rate was 2.6 l/min, but dropped to 1.7 l/min.It was later reported that the second set of pads where switched out for a third set of pads and the flow rate increased to an optimal level and no further issues were noted.Therapy was continued with no further issues.Per biomed, one set of pads were obtained and tested.System diagnostic were reviewed and everything was within specification (the flow rate was 1.6lpm, the inlet pressure was -7.1psi, and the circulation pump was working at 48%).Reservoir level was 5.The pad was connected one at a time.When chest pad was connected, the flow rate was 1.3lpm, the inlet pressure was -6.9 lpm, and the circulation pump was working at 60%.When a thigh pad was connected, leaking was noted.The biomed confirmed that both thigh pads had cuts in the clear tubing under the foam.The cuts were under the foam and the foam was intact.The chest pads appeared intact.The pads would be returned to 2nd floor icu.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTICSUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7393034
• MDR Text Key: 104543467
• Report Number: 1018233-2018-01027
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 317-07-02
• Device Lot Number: NGBY3146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 75