MAUDE Adverse Event Report: KING SYSTEMS UNIVERSAL FLEX2 BREATHING CIRCUIT; ANESTHESIA BREATHING CIRCUIT

Model Number KNCF375-6121Z

Device Problem Material Separation (1562)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Patient's co2 began to rise after induction of anesthesia.Clinician began treatment protocol for malignant hyperthermia (mh).Patient's co2 did not respond adequately to mh protocol, so breathing circuit was removed and a bag-valve-mask was used to ventilate the patient at which time it was discovered that the inspiratory (inner) tube of the coaxial breathing circuit had detached from inner tube of the cuff.Patient's co2 levels improved and patient was transferred to the icu, and later transferred to another facility where she could be evaluated by a interventional radiologist for possible deep vein thrombosis in her arm as a result of the mh therapy.

• Brand Name: UNIVERSAL FLEX2 BREATHING CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesville IN 46060
• Manufacturer (Section G): KING SYSTEMS; 15011 herriman blvd.; noblesville IN 46060
• Manufacturer Contact: wayne nethercutt ; 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 6590484
• MDR Text Key: 76049617
• Report Number: 1824226-2017-00003
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 00612649204840
• UDI-Public: (01)00612649204840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2019
• Device Model Number: KNCF375-6121Z
• Device Catalogue Number: KNCF375-6121Z
• Device Lot Number: 1985606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• 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 Outcome(s): Other