MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. 9064/M/711BRSA059/0001; HME,FILTER,ADLT,COMPACT,STRAIGHT,W/PORT

Model Number	DYNJAAHME9
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the facility that the heat and moisture exchange (hme) filter disconnected from the device blocking the patient's airway requiring resuscitative measures.Reportedly the hme was placed after the circuit was attached to the suction ballard 6 in the corrugated tubing before the patient endotracheal tube (ett).There were no procedures being performed at the time of the incident.Within hours of the device being placed the inside sponge material came loose from inside the hme and was lodged in the breathing circuit blocking the patient's airway which resulted in cardiac arrest of the patient as he was unable to receive any breaths from the ventilator.Advanced cardiac life support (acls) was immediately initiated and the patient was able to be resuscitated with cardiopulmonary resuscitation (cpr).The suction ballard and hme housing were removed from the ventilator circuit.The obstruction was removed from the tip of the ballard with forceps.The patient's oxygen level stabilized and the patient was discharged from the hospital without further incident or consequence.The ventilator settings at the time of the incident were set to prvc, rr 20, vt 350, fio2 25%, peep +5.There was no active humidification being used.The facility reported there were no signs of mishandling noted to the product, filters or packaging and no reported force required during connection of the filter.This is the first time that the facility has used this product.No sample has been returned to the manufacturer as of the filing of this report.A root cause has not been determined.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported by the facility that the heat and moisture exchange (hme) filter disconnected from the device blocking the patient's airway requiring resuscitative measures.

• Brand Name: 9064/M/711BRSA059/0001
• Common Device Name: HME,FILTER,ADLT,COMPACT,STRAIGHT,W/PORT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10402234
• Report Number: 1417592-2020-00093
• Device Sequence Number: 2943389
• Product Code: BYD
• UDI-Device Identifier: 10884389120484
• UDI-Public: 10884389120484
• Combination Product (Y/N): N
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJAAHME9
• Device Catalogue Number: DYNJAAHME9
• Device Lot Number: 40020030152, 40020050053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-20-123
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 65