MAUDE Adverse Event Report: CARDINAL HEALTH MALTA 212 LTD FLEX ADVANTAGE 3000ML GEL VAC; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651930PG

Device Problem Aspiration Issue (2883)

Patient Problem No Information (3190)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.A review of the manufacturing device history record could not be conducted as the lot number was not provided.Likewise, we have analyzed the provided information but with the limited information we cannot determine the specific cause for such concern.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Note: if the event sample is received at a later date and provides a different conclusion, an addendum report will be written.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.Trending of past product quality reports indicate that this is the 1st reported incident for the loss of vacuum observed with the flex product line when used in tandem set up in the past three calendar years.No further action is planned at this time.

Event Description

In tandem set up, it was noticed loss of aspiration while connected to vacuum plug in.Depression mentioned -800 mmbar first and decreased itself to -500 mmbar.Aspiration rate and pressure manometer port checked and they were correct.Patient outcome: not efficient aspiration during extensive bleeding.Hospital measures: biomedical unit and medline were informed.Proposal: reduce liner size from 3l to 1,5l.Not sufficient - the system should provide a full volume and an intensive suction.

• Brand Name: FLEX ADVANTAGE 3000ML GEL VAC
• 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: 7128952
• MDR Text Key: 96065996
• Report Number: 1423537-2017-00143
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65651930PG
• Device Catalogue Number: 65651930PG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2017
• 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