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

Catalog Number 317-03

Device Problem Output below Specifications (3004)

Patient Problem 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 the pads were giving low flow, as a result therapy was interrupted and the patient was taken off of the device and put on percutaneous cardiopulmonary support.

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.

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.

Manufacturer Narrative

Received 1 set of 4 used arcticgel pads with the original unit packaging.Visual inspection noted no obvious defects.The trim pattern was found to be within specifications and the energy connectors were found to be free of damages and presented with a good connection.A functional evaluation was performed via a flow rate test.The pads were connected to the arctic sun machine model 2000 for 10 minutes, see details below: left chest pad: a total of 1.05 l/min m2 of flow rate was registered during the test due to the pad was noted as crushed.Left thigh pad: a total of 1.58 l/min m2 of flow rate was registered during the test due to the pad was noted as crushed.Right chest pad: a total of 3.58 l/min m2 of flow rate was registered during the test.Right thigh pad: a total of 5.79 l/min m2 of flow rate was registered during the test.According to the test method the flow rate was not within specifications on the left chest and left thigh pad as the flow rate must be above 2.4 l/min m2.The right chest pad and the right thigh pad was found to be within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was confirmed as a manufacturing related issue.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.¿ (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: 5462162
• MDR Text Key: 39447608
• Report Number: 1018233-2016-00204
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2016

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
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 317-03
• Device Lot Number: NGZG2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2016; 04/13/2016; 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2015
• 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): Required Intervention