MAUDE Adverse Event Report: CARDINAL HEALTH MALTA 212 LTD MEDI-VAC ® FLEX ADVANTAGE® - 1000 ML; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651910

Device Problem Device Inoperable (1663)

Patient Problems Aspiration/Inhalation (1725); Cardiopulmonary Arrest (1765); Death (1802); Vomiting (2144)

Event Date 10/04/2017

Event Type  Death  

Manufacturer Narrative

Investigation in progress awaiting further clarification of the report from the end user customer.A follow-up report will be filed.

Event Description

Event description: after a vascular thrombectomy procedure, a (b)(6) patient presented a compartment syndrome 1 day post-op, and syndromes of digestive occlusion 2 days post-op.At 7:00pm, the patient suffered respiratory arrest with important vomiting.The doctor intended to perform a broncho-aspiration using the medic-vac system and it was impossible: the system did not work.The doctor used a second medi-vac system on a trolley and the aspiration worked.Consequences: delay in taking-over the patient.It was impossible to perform a ventilation due to the impossibility to do the aspiration in a timely manner.The patient died.Conservative actions taken by the hospital: the wall fixation has been checked by the qualified technicians and seemed to be working properly.Review of the devices used during the reanimation: the medi-vac system is used without a trolley.The ¿quick notice¿ provided by the manufacturer does not mention such aspects.An information has been circulated to all the services in the hospital to remind the good instructions for use.

Manufacturer Narrative

Initial report filed on 10/26/2017.Additional information received from the end user customer.The investigation is in progress.A follow-up report will be filed when the investigation is completed.

Manufacturer Narrative

The investigation is completed.To investigate the concern, on 7 november 2017, our qa manager, ra manager and sales manager of cardinal health visited (b)(6) hospital.They met with the pharmacist of the (b)(6) who is responsible for the vigilance.After an initial meeting with the pharmacist, we have concluded that the assignable root cause is related to improper set-up of the flex advantage system.The pharmacist confirmed that the reusable hard canister ¿on / off¿ valve was set in the ¿off¿ position which caused the non-function of the unit.The pharmacist confirmed that the reusable hard canister with inserted liner was also placed on the floor and not attached to a wall mount or in a roll stand as illustrated in the ifu.She confirmed that their personnel followed the medline ¿quick reference¿ one pager which does not illustrate the warning information and does not mention that the device should be attached to a wall mount or in a roll stand as illustrated on the cardinal health ifu.As set out among the warnings in the ifu, premature shut off may occur if the reusable hard canister is bumped or moved suddenly in a vertical position, therefore the device should be placed in vertical position at all times.Nevertheless both the ¿quick reference¿ one pager and the product ifu illustrate that the reusable hard canister ¿on / off¿ valve should be in the ¿on¿ position at all times while operating the device.A review of the manufacturing device history record could not be conducted because the lot number was not communicated.However based on the investigation, we have concluded that the medi vac flex advantage liners are free of defects or functional problems.Trending of past product quality reports indicate that this reported incident is isolated to (b)(6) only.Thus as a preventive action, cardinal health issued a field safety notice to customers based in (b)(6) emphasizing the language and warnings stated in the product ifu and the risks associated with incorrect use of the device.The (b)(6) quick reference note will be updated to the cardinal health quick reference guide to ensure there will be no repeat events.We will continue to monitor trends and utilize the information as part of continuous improvement.

• Brand Name: MEDI-VAC ® FLEX ADVANTAGE® - 1000 ML
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer (Section G): CARDINAL HEALTH MALTA 212 LTD; a51, industrial estate; marsa MRS30 00; MT MRS3000
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6980638
• MDR Text Key: 90350144
• Report Number: 1423537-2017-00136
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 65651910
• Device Catalogue Number: 65651910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/16/2017
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR