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 Suction Problem (2170)

Patient Problem Aspiration/Inhalation (1725)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.However, one picture was received from the customer for evaluation.A visual examination of the picture was completed with production, engineering, and quality management.The picture depicted a patient room in which the outer canister (65652-611) with a flexible liner (65651910) was set up directly on the floor with tubing attached to a vacuum regulator toward the ceiling.Per the directions for use, if not already in a mounting bracket, place reusable hard canister into bracket on a roll stand or wall mount.If the canister and liner was directly on the floor during use, this may increase the risk of suction being delayed; however, without the actual event sample involved in the customer incident and duplication of the non-conformance, no specific assignable cause can be determined regarding the reported incident.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.

Event Description

A (b)(6) patient was treated for an idiopathic thoracolumbar scoliosis of adolescence.In post-surgery, during a gastric aspiration a medi-vac suction system, connected to ch12 nasogastric probe (fitting bucket) was used.Several suction sets and several regulators (depression rate: from 0 to -200 mbar) were used by the nurses before obtaining the aspiration.Clinical consequences: procedure delayed.Practitioner performed a manual aspiration using a syringe.Healthcare professionals were doubtful on their ability to achieve a rapid and effective aspiration in an emergency situation.Measures: the defective canisters were discarded.Despite the previous medi-vac system information of use to personal, the intended use is still unknown (no canister fixation, no reinforced tubing from vacuum source to the canister).

• 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 ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 7666813
• MDR Text Key: 113873602
• Report Number: 1423537-2018-00220
• 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: distributor,foreign,health pr
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention