MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS ARCTIC SUN GEL PADS

Catalog Number 317-07-02

Device Problem No Flow (2991)

Patient Problem Underdose (2542)

Event Date 05/17/2016

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 during therapy the pads were giving no flow; as a result, therapy was discontinued and the patient's temperature was maintained using other means.

Manufacturer Narrative

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

Manufacturer Narrative

Received 2 sets of 4 used arcticgel pads with the original unit packaging. The complaint is confirmed as cause unknown. During the visual evaluation, the following was found: set #1: visual inspection noted that the energy connectors have been damaged (energy connectors were collapsed where the energy connector is joined to the water supply and returned lines of the arctic sun) on the left thigh pad. No other damage was noted on the others pads. The trim patterns of the pads were found to be correct, and no obvious defects were noted in the laminate of the pads. The energy connectors were found to be correctly labeled. No obvious defects were found. Set #2: no damages were noted on the pads. The trim patterns of the pads were found to be correct, and no obvious defects were noted in the laminate of the pads. The energy connectors were found to be correctly labeled. No obvious defects were found. Per the functional evaluation, the pads were submitted to the flow rate test with the arctic sun machine model 2000. According to the flow rate test, the flow rate of the left chest pad (set #1) was never stabilized because the energy connector was damaged (deformed) causing an air leakage. The left thigh pad, right chest pad and right thigh pad were found acceptable. Set #2's flow rate of the left chest pad, left thigh pad, right chest pad and right thigh pad were all found acceptable. The flow rate for this product must be above 2. 4 l/min m2. 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 full pad kit. ¿ (b)(4). 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.

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5719263
• MDR Text Key: 48191694
• Report Number: 1018233-2016-00729
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 317-07-02
• Device Lot Number: NGAP0217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/11/2016 Patient Sequence Number: 1