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

Catalog Number 317-09

Device Problems Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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.

Event Description

It was reported that the device produced low flow, after the patient returned from a computerized tomography (ct) scan.The pads were previously emptied and refilled, and also disconnected and reconnected.The nurse then placed the device into manual mode.The flow rate was 1.7 lpm, the inlet pressure was -6.9 psi, the chiller pump was operating at 47%, and the device pump hours were 686.The nurse then connected the right chest pad.The flow rate was 1.8 lpm, and the ip was -1.3 psi.The nurse then moved the pad to another valve set.The flow rate was 0.4 lpm, and the ip was -6.9 psi.She then attached right thigh pad.The nurse stated that the clamps were loose, and one came off.Subsequently, the flow increased to 1 lpm, and the ip was -7 psi.She then connected the left thigh pad.The flow rate was 0 lpm, and the ip was -0.8 psi.The nurse moved the pad to another valve set, and the flow rate was 0.8 lpm, and the ip was -3.8 psi.She then disconnected that pad and connected the left chest pad.The flow rate was 0.2 lp, and the ip was -2.1 psi.As a result; the pads were replaced with a new set of pads, and therapy was resumed without further issues.

• Brand Name: ARCTIC GEL 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6197884
• MDR Text Key: 63610846
• Report Number: 1018233-2016-01848
• 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: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• 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): Required Intervention