MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., PORTEX® SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number NLD-15545C-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

The user facility submitted a medwatch; there was not a user facility reference number denoted on the medwatch; therefore, it could not be referenced in the manufacturer's medwatch.Information taken from the user facility's report was used to fill in sections of this report.The manufacturer completed sections on this report.The manufacturer made some corrections to the user facility's reported information in sections of this medwatch.Note, no edits were made on the original user facility medwatch.Please notice the changes made by manufacturer: date of report was updated to today's date (04/14/2016).Comment added, the first incident was captured under the manufacturer's reference number: 2183502-2016-00791.The second incident referred to above is being captured on the manufacturer's reference number: 2183502-2016-00792.The user facility reported 2 events on 1 medwatch.The manufacturer has filed 2 separate reports to capture both events.All of section for suspect medical device corrected and filled out.As per direction received from the fda on 12/9/1999; the manufacturer completes block for suspect medical device in it's entirety regardless if the user facility completes all or any of block for suspect medical device, therefore block d may contain corrected and/or additional data.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Two (2) incidents.1 spinal given in operating room (o.R.) for pregnant pt.For cystoscopy.Sab placed w/o any issues.Waited 15min and pt had no effect from sa'b.Had to convert to general anesthetic.Chavezmiramontes, morairna fin 97614762 1 spinal given for post partum tubal.Sab took close to 12 min to "set up." surgeon still had to inject local in order keep pt comfortable.Ref # (b)(4) lot 3115757 ref# nld (b)(4) l:ot 3093098.**the first incident was captured under the manufacturer's reference number: 2183502-2016-00791.The second incident referenced is being captured on the manufacturer's reference number: 2183502-2016-00792.**.

Manufacturer Narrative

One used warming device, power code, warming house from a different warming device model, and a warming blanket were returned for product investigation.A used filter and case were also returned, and the filter was used during testing.During visual inspection of the case, no defects or abnormalities were found.During functional testing, the returned accessories were assembled on the warming device and the device was turned on.The device began to perform its self-test; however the fan/motor was not blowing air.The investigator adjusted the temperature of the device to 36 degree celsius and the device heater engaged; however, the blower continued to be non-functional.Due to the lack of air flow, the thermostat was not cooled which resulted in a heater thermostat disconnect alarm.The motor, mains, and pcb were replaced on the device.After replacement, the device was powered on and performed the start-up function, the blower was found to be functional and no defects or abnormalities were observed.The device was set to each of its three different temperature setting; all temperatures were found within specification.The cause of the reported issue is most likely due to the age of the device; however, product evaluation and inspection could not determine the root cause for the non-functional blower.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5579128
• MDR Text Key: 42747342
• Report Number: 2183502-2016-00792
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: NLD-15545C-21
• Device Lot Number: 3093098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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 Age: 32 YR