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

Catalog Number 317-00

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2016

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 two single universal pads, used on a pediatric patient, had low flow.The first pad had a flow of about 0.5 lpm; as a result, the pad was swapped with a new pad.However, that pad also had low flow.The therapy was continued and completed with the two alleged low flow pads connected to the fluid delivery line.The flow of the two pads combined was about 1.1 lpm.

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 two single universal pads, used on a pediatric patient, had low flow.The first pad had a flow of approximately 0.5 lpm; and as a result, the pad was replaced with a new pad.However, the replacement pad also had low flow.The therapy was continued and completed with the two pads (that allegedly produced low flow), connected to the fluid delivery line.The flow of the two pads combined was approximately 1.1 lpm.

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 two single universal pads, used on a pediatric patient, had low flow.The first pad had a flow of approximately 0.5 lpm; and as a result, the pad was replaced with a new pad.However, the replacement pad also had low flow.The therapy was continued and completed with the two pads (that allegedly produced low flow ), connected to the fluid delivery line.The flow of the two pads combined was approximately 1.1 lpm.

Manufacturer Narrative

Received 1 used universal pad only.The reported event was unconfirmed, as the problem could not be reproduced.The visual inspection noted no obvious defects that would have contributed to the reported problem.The pad was reviewed and use evidence was noted.The pad 's trim pattern was found to be correct.The energy connector was found free of damages and presented a good connection.The functional evaluation was conducted as follows: the pad was submitted to the flow rate test under test method tm7600515 with the arctic sun machine model 2000 the pad was connected to the arctic sun machine model 2000 during 10 minutes, see details below: * universal pad: a total of 5.15 l/min m2 of flow rate were registered during the test.According the test method tm7600515 the flow rate was found to be acceptable on the returned pad.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 fullpad kit.¿ (b)(4): "l" (b)(4): "nl" 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 two single universal pads, used on a pediatric patient, had low flow.The first pad had a flow of approximately 0.5 lpm; and as a result, the pad was replaced with a new pad.However, the replacement pad also had low flow.The therapy was continued and completed with the two pads (that allegedly produced low flow ), connected to the fluid delivery line.The flow of the two pads combined was approximately 1.1 lpm.

• Brand Name: ARCTIC SUN GEL PAD
• Type of Device: ARCTIC SUN SUN GEL PAD UNIVERSAL
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6155992
• MDR Text Key: 61873180
• Report Number: 1018233-2016-01769
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 317-00
• Device Lot Number: NGAN4034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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