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

Model Number	KNCF375-6121Z
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem 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
• Common Device Name: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; 15011 herriman blvd.; noblesville IN 46060
• MDR Report Key: 6590484
• Report Number: 1824226-2017-00003
• Device Sequence Number: 746354
• Product Code: CAI
• UDI-Device Identifier: 00612649204840
• UDI-Public: (01)00612649204840
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other