MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 8888571299

Device Problem Suction Problem (2170)

Patient Problem Pneumothorax (2012)

Event Date 05/20/2017

Event Type  Injury  

Manufacturer Narrative

Submit date: 9/6/17.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure on (b)(6) 2017, doctor made change of preurovac cx in its round and indicates was installed incorrectly, that it lacked water for the vacuum, they called the specialist that confirms the pleurovac was bad positioned it was made the proper installation to correct the error.The specialist said the device was different to the one that he normally used and he made a bad connection between the device and the patient so the vacuum was not ok.Details of injury and patient recovery was pneumothorax in 80% in the right lung.The patient was alive with no injury.

Manufacturer Narrative

The complaint report indicates that no sample is available in connection with this complaint report.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).A review was complete on the dhr for lot 15l007fhx and found that there were no deviations noted during the manufacturing of the lot.The lot met all acceptance criteria prior to release.During manufacture of aqua seal devices, each unit is functionally tested to ensure it functions properly.Also independent qa sampling is complete to ensure there are no defects.Based on the complaint description the most probable root cause is that the unit was not set up correctly as it indicates the unit was installed incorrectly, that it lacked water for the vacuum.If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.A review of the complaint tracking system for previous complaints against the lot number found no previous complaint against this lot number.The associated data will be fed into the risk management quarterly report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AQUA-SEAL
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6846072
• MDR Text Key: 85015325
• Report Number: 9611018-2017-05009
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 20884521060965
• UDI-Public: 20884521060965
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 15L007FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR