MAUDE Adverse Event Report: MOLECULAR PRODUCTS LTD MEDISORB PREPACKED CARTRIDGE, WHITE TO VIOLET; ABSORBENT, CARBON-DIOXIDE

Model Number 427000100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Toxicity (2333)

Event Date 04/06/2015

Event Type  Injury  

Event Description

The following was reported to carefusion ((b)(4)) - customer submitted a complaint alleging elevated cohb levels were found in the patients blood during procedure. sales rep noted the following " operating room #30 is where occurrence happened.1st case of the day-monday morning.No definite answer as to if machine was on all weekend.Not sure if medisorb canisters that morning were new/old aestiva machine-s5 module-ecaio double width gas module, i asked how patient was and patient doing fine-per dr.Speery.Machine was still in use the remainder of the day and all cases were fine machine used all week and all cases were fine."  samples are available, sent ups call tag to sales rep to obtain sample.Additional detail - in initial email to sales rep from customer (attached in initial email), it is stated that upon entering the room the machine was found to be turned on.

Manufacturer Narrative

(b)(4) - a complaint sample is available and has been sent to the manufacturer for evaluation.Upon receipt of the evaluation, a follow-up will be submitted.

Manufacturer Narrative

Follow-up mdr submission for (b)(4)- four samples were returned to molecular products for evaluation; 2 canisters which were in use at the beginning of the procedure and 2 canisters put into use during procedure.The units in use at the time of the reported incident were both desiccated.It would be possible for degredation of the anaesthetic agent to occur, producing carbon monoxide.The most likely cause of desiccation is dry gas flow at basal flow passing through the units over the weekend; this is considered a misuse condition.Analysis of the dhr for this lot indicates that the material, when originally packed, met the necessary performance requirements.There have been no other occurences of the reported issue over the last 2 years.The reported issue will continue to be trended and evaluated.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.Corrected data: investigation completion date.(b)(4).

• Brand Name: MEDISORB PREPACKED CARTRIDGE, WHITE TO VIOLET
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): MOLECULAR PRODUCTS LTD; parkway; harlow business park; essex IL CM19 5FR; UK CM19 5FR
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway; harlow business park; essex CM19 5FR; UK CM19 5FR
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4769917
• MDR Text Key: 5791987
• Report Number: 3010838917-2015-00008
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 427000100
• Device Lot Number: 6991114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/13/2015; 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention