MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620; ANESTHESIA GAS MACHINE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported 9 patients were infected in one day while using one anesthesia machine.It was reported that a bottle of propofol that was used during the case was found to have bacteria identified as acinetobacter which was the same bacteria identified in one of the patients.It was further reported that the inhaled anesthetic was not the cause of the reported injuries.

Manufacturer Narrative

Ge healthcare product engineering performed an investigation of this event.It was determined that the blood poisoning was not caused by or contributed to by the carestation machine.The bacteria was identified in a patient and a bottle of propofol.That drug is injected directly into the blood stream via an iv.Per ge healthcare medical directors, the speed of the disease progression is not consistent with contamination of the breathing system.If the breathing system had been the cause of the contamination, the infections would have started with pneumonia and progressed to sepsis.The onset of the sepsis was too fast to have been caused by contamination of the breathing system but would be consistent with contamination of the iv drugs.The machine was checked out on site by a ge healthcare service partner and found to be operating properly.There was no evidence of anesthesia machine contamination provided.Ge healthcare product engineering evaluated the system logs and confirmed no malfunction with the unit occurred.Based upon the investigation and additional information received, it has been determined that the ge healthcare carestation 620 did not cause or contribute to the patient blood poisoning.

• Brand Name: CARESTATION 620
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8200640
• MDR Text Key: 131537753
• Report Number: 9710602-2018-00330
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization