MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; MEDLINE ANESTHESIA CIRCUIT

Model Number DYNJAAF6380

Device Problem Detachment Of Device Component (1104)

Patient Problem Hyperthermia (1909)

Event Date 10/23/2015

Event Type  Injury  

Event Description

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.

• Brand Name: MEDLINE
• Type of Device: MEDLINE ANESTHESIA CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mudelein IL 60060
• MDR Report Key: 5235235
• MDR Text Key: 31594440
• Report Number: MW5057939
• Device Sequence Number: 1
• Product Code: OFP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJAAF6380
• Device Lot Number: 15SB0503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 19