MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT 1000CC FLEX CANISTER; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65652-611
Health Effect - Clinical Code	Death (1802)
Date of Event	05/01/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.Customer stated sample is not available; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Without a lot number or the actual event sample involved in the incident and duplication of the non-conformance, no specific assignable cause can be determined regarding the reported incident.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.
Event or Problem Description
(b)(6) patient, hospitalized for the care of a patient febrile neutropenia following chemotherapy for evolutionary t-cell lymphoma.On the night of (b)(6) to (b)(6), the patient had a sudden dyspnea with cardiopulmonary arrest, taken care of by a doctor (from intensive care unit).The patient vomits abundantly, causing a defect of ventilation.An intubation was necessary.The doctor intended to perform a broncho-aspiration using the medic-vac system.The facility reported that this was not possible because the system did not work (no depression in the patient's manifold).The use of a second system permitted to obtain a suction.Consequences : procedure delayed.The facility reported that ventilation was not possible due to aspiration defect.The cardio-respiratory reanimation was stopped due to the serious neurological prognosis.The patient died.

• Brand Name: 1000CC FLEX CANISTER
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 7627023
• Report Number: 1423537-2018-00204
• Device Sequence Number: 1396586
• Product Code: GCX
• UDI-Device Identifier: 10885380042638
• UDI-Public: 10885380042638
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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?: No
• Operator of Device: Physician
• Device Model Number: 65652-611
• Device Catalogue Number: 65652-611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 59 YR