MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ANES CIRC ADULT 90IN EXP-LF

Catalog Number	DYNJAA9965D
Health Effect - Clinical Code	Swelling (2091)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a craniotomy and tumor removal/resection procedure the patient was in the prone position, toward the end of the procedure, the end-tidal co2 (etco2) was low and the patient was hard to ventilate.The surgeon noticed that the patient was experiencing intracranial pressure during the time that the patient was experiencing low end-tidal co2 (etco2).An additional anesthesia provider was called in to assist and replaced the entire anesthesia circuit, without a filter, after which the intracranial pressure was eliminated, the surgical site was closed and no additional medical intervention was required.The anesthesiologist stated that he evaluated the anesthesia circuit after the set was removed from the patient and he felt the filter was full of moisture.Due to the patient being in the prone position and the drapes covering the filter, the moisture in the anesthesia circuit filter was not noticed during the procedure.After the anesthesia circuit changed the surgeon was able to close the surgical site without further incident.There was no serious injury, follow-up medical care or medical intervention required.The filter was not returned for evaluation.A root cause cannot be determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.Incorrect mfr report number submitted on original report.
Event or Problem Description
It was reported that moisture in the filter was not allowing the pressure to release during a procedure.

• Common Device Name: ANES CIRC ADULT 90IN EXP-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7450744
• Report Number: 1417592-2017-00070
• Device Sequence Number: 13796158
• Product Code: CAI
• UDI-Device Identifier: 10889942539192
• UDI-Public: 10889942539192
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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 Catalogue Number: DYNJAA9965D
• Device Lot Number: 17GB6060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 04/23/2018
• 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