MAUDE Adverse Event Report: COVIDIEN 30318 AQUA-SEAL CDU; CHEST DRAINAGE UNIT

Model Number 8888571299

Device Problems Air Leak (1008); Suction Problem (2170); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/01/2016.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on 08/01/2016 that a customer had an issue with a chest drainage unit.The customer reports hat the patient underwent surgery for a mitral valve replacement.When coming out of surgery two chest tubes one pleural and another to the mediastinum were placed.The patient was then moved to the icu where it was discovered that the drainage systems aqua seal did not work.There is no vacuum and air is escaping which is evident in one of the white tops (where it is filled with solution) there is a sound (whistle).The physiotherapist tried to check what happened with the system by pressing the white cap which shows whether or not the system works.There was no patient harm.

Manufacturer Narrative

An investigation of the reported condition was performed.During the manufacturing process, units are 100% functionally tested to ensure that they function correctly, all defective vessels are discarded.Therefore the probable root cause of the reported condition is that the product was damaged during transit.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).Unfortunately without a sample we are unable to confirm the reported condition.If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the lot.Based on the above no further action is required at this time.The associated data will be fed into the risk management quarterly report.

• Brand Name: 30318 AQUA-SEAL CDU
• Type of Device: CHEST DRAINAGE UNIT
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; co. offaly; tullamore ; EI
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5836967
• MDR Text Key: 52196307
• Report Number: 9611018-2016-00039
• Device Sequence Number: 1
• Product Code: KDQ
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 15J003FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1