MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-05-13 for MEDISORB PREPACKED CARTRIDGE, WHITE TO VIOLET 427000100 manufactured by Molecular Products Ltd.
[5791987]
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.
Patient Sequence No: 1, Text Type: D, B5
[13288045]
(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.
Patient Sequence No: 1, Text Type: N, H10
[23036937]
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.
Patient Sequence No: 1, Text Type: N, H10
[63095684]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010838917-2015-00008 |
| MDR Report Key | 4769917 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-05-13 |
| Date of Report | 2016-12-19 |
| Date of Event | 2015-04-06 |
| Date Mfgr Received | 2015-05-18 |
| Date Added to Maude | 2015-05-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | MOLECULAR PRODUCTS LTD |
| Manufacturer Street | PARKWAY HARLOW BUSINESS PARK |
| Manufacturer City | ESSEX CM195FR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CM19 5FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDISORB PREPACKED CARTRIDGE, WHITE TO VIOLET |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2015-05-13 |
| Returned To Mfg | 2015-05-01 |
| Model Number | 427000100 |
| Lot Number | 6991114 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLECULAR PRODUCTS LTD |
| Manufacturer Address | PARKWAY HARLOW BUSINESS PARK ESSEX IL CM195FR UK CM19 5FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-13 |