MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TRI-LUMEN FILTERED TUBE SET; INSUFFLATOR, LAPAROSCOPIC

Catalog Number ASM-EVAC1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abnormal Blood Gases (1034); Infiltration into Tissue (1931); Forced Expiratory Volume Increased (2431)

Event Date 04/18/2020

Event Type  Injury  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported issues with the asm-evac1, trilumen filtered tube set that occurred (b)(6) 2020 at (b)(6).The doctor performed an exploratory laparoscopy with lysis of adhesions using airseal as the insufflation with asm-evac1 & 5mm airseal port.The procedure was 5.5 hours & the patient was repositioned several times ranging from trendelenburg, reverse trendelenburg & airplaned left positions.About 2 hours into the case, patient became increasing hypercapnic up to a paco2 of 91.She got progressive subcutaneous emphysema throughout case & required intensive care unit (icu) admission.The patient was a (b)(6)female weighing (b)(6).It was reported there was a small serosal injury that occurred on the bowel adhered to the anterior abdominal wall with trocar placement that required upsizing of a port to a 12mm balloon port but was repaired without difficulty.There were numerous adhesions repaired throughout the abdomen & the hypercapnia was related to abdominal wall fascia disruption during adhesiolysis.Extensive adhesions of small bowel to the midline anterior abdominal wall & interloop adhesions were being removed.Five trocars were in use.The surgeons did confirm placement multiple times, but during the case the black lines were not always visible.The surgeons felt they needed to proceed to remove the adhesions even after the increasing hypercapnic and subq emphysema.The anesthesia team attempted to decrease the paco2 by increasing the minute ventilation.The subcutaneous emphysema was palpated in her bilateral lower extremities, bilateral lateral thorax, bilateral upper extremities & upper chest & neck.The subq emphysema was confirmed in the chest & neck on chest x-ray immediately post-op and it was confirmed in the extremities through palpation.The patient was in icu overnight & moved to the unit/ floor the next day.Per the patient's medical notes, the subq emphysema resolved by post-op day 2.The patient was noted to have history of hiatal hernia, prior abdominal surgeries, adhesiolysis & two c-sections.Comorbidities of hypertension, gastroesophageal reflux, hiatal hernia, renal artery aneurysm were also noted.It was confirmed the procedure was completed, remained laparoscopic but did switch from airseal to regular tubing.No impact to the patient was confirmed and she is currently discharged with no complications noted at the 2 week post-op visit.This report is being raised on the basis of patient injury for the increasing hypercapnic, progressive subcutaneous emphysema throughout multiple regions of body and the unplanned icu admission.

Manufacturer Narrative

D11: the as-ifs1 and ias5-120lp devices were added to this record as the devices were used in the procedure and involved in the reported event.There were no reported issues noticed with the as-ifs unit, tubing or port, however, the surgeons did switch from the airseal to regular tubing.Because of this statement, the filing of this event has been reported under the asm-evac1 trilumen filtered tube set and not the as-ifs1 or the 5mm airseal port.The as-ifs1 (unknown serial #) and the 5mm airseal port are listed as concomitant devices.H10: the device in question will not be returned for evaluation and no photographic evidence has been provided.Therefore, no issue with the trilumen tubing set can be verified, and a root cause cannot be established.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.The instructions for use (ifu) provides the user with information regarding proper care and warnings for use of this device and of the airseal.The ifu also advises that higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Additional comment: please note the patient was not intubated post-operatively & no davinci robot device was in use.There were no alarms reported from the airseal unit and the pressure setting being used with the as-ifs unit were <15.

• Brand Name: TRI-LUMEN FILTERED TUBE SET
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 10189428
• MDR Text Key: 201062175
• Report Number: 3007305485-2020-00265
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASM-EVAC1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5MM AIRSEAL PORT, DETAILS UNKNOWN; AIRSEAL UNIT, DETAILS UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 60