MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANISTER 1200CC GUARDIAN; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-212

Device Problem Suction Problem (2170)

Patient Problem Death (1802)

Event Date 07/03/2018

Event Type  Death  

Manufacturer Narrative

Complaint forwarded to the manufacturing site for investigation.A follow-up report will be filed once sample is evaluated and the investigation completed.

Event Description

While working on a patient, staff reports that the suction was working, then stopped.The patient did pass away, but hospital has reported that they believe the patient death was not as a result of the suction canister.It did delay suctioning in the mouth of the patient after intubation, but hospital has reported patient coded a second time at a later time.

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.One sample was received for evaluation.A visual examination of the canister was completed by quality and engineering management.No visual non-conformities were noted.Functional testing of the returned sample and five samples from our current inventory was completed by our laboratory personnel to determine the flow and leak rate.All units functioned as designed.Based on the investigation and testing of the returned sample, no specific assignable cause can be determined as the returned unit functioned as designed.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 Description

While working on a patient, staff reports that the suction was working, then stopped.The patient did pass away, but hospital has reported that they believe the patient death was not as a result of the suction canister.It did delay suctioning in the mouth of the patient after intubation, but hospital has reported patient coded a second time at a later time.

• Brand Name: CANISTER 1200CC GUARDIAN
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 7737095
• MDR Text Key: 115645200
• Report Number: 1423537-2018-00229
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00630140152538
• UDI-Public: 00630140152538
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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
• Device Operator: Health Professional
• Device Model Number: 65651-212
• Device Catalogue Number: 65651-212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 33 YR
• Patient Weight: 84