MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-15 for MEDLINE DYNJAAF6380 manufactured by Medline Industries, Inc..
[31594440]
After an uneventful inhalation induction of general anesthesia, iv placement, and a traumatic naso-tracheal intubation, there was a dramatic rise in end-tidal carbon dioxide noted via capnography. As this is a hallmark sign of malignant hyperthermia, the clinician immediately initiated protocol to treat the syndrome. During initial measures to deal with the problem, terminating the inhalation triggering agent and initialing cooling measures while the antidote (dantrolene) was being prepared, it was found that an occult disconnect of the proximal end of the inspiratory limb of the f-type anesthesia circuit hose had occurred, thus causing a dramatic "rebreathing" of exhaled carbon dioxide. Malignant hyperthermia protocol had been started, but dantrolene had not been given. There was a return to normal carbon dioxide values after replacement of the anesthesia circuit and there were no untoward sequelae from the event. Dates of use: (b)(6) 2015. Reason for use: this is an anesthesia circuit used for general anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057939 |
| MDR Report Key | 5235235 |
| Date Received | 2015-11-15 |
| Date of Report | 2015-11-15 |
| Date of Event | 2015-10-23 |
| Date Added to Maude | 2015-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE |
| Generic Name | MEDLINE ANESTHESIA CIRCUIT |
| Product Code | OFP |
| Date Received | 2015-11-15 |
| Returned To Mfg | 2015-11-02 |
| Model Number | DYNJAAF6380 |
| Lot Number | 15SB0503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-15 |