MAUDE Adverse Event Report: COVIDIEN ARGYLE ALTITUDE DRY SUCT CDU; CHEST DRAINAGE UNIT

Model Number 8888571370

Device Problems Leak/Splash (1354); Suction Problem (2170)

Patient Problem No Information (3190)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

It was reported to covidien on 06/10/2015 that a customer had an issue with a chest drainage unit (cdu).The customer states that they attempted to use the altitude chest drain unit on a patient and the cdu suction regulator would not hold suction and resulted in a loss of suction.The facility tried and additional altitude chest drain unit and the same loss of suction occurred and the device began to leak fluid.The customer further stated that the suction / leaking noise was coming from the base of the dial (not the white part, but the blue piece).After they noticed the issue on the first cdu, they replaced it with a new unit.When the noise started to occur on the second unit the nurse put tape around the area where the noise was occurring and this stopped the problem.Both of these units were from the same lot.The following morning, the cdu was replaced again (different lot) with a new unit and the noise stopped and proper suction was restored.The md discontinued the cdu about 5 hours later.The unit was connected to the patient every time the issue occurred.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Three unopened units were returned to the manufacturing facility.The units were opened.Visual examination finds that there was no obvious damage to the units that could cause a leak.The units were then tested and passed all testing as per procedure.The reported condition could not be found with the returned units.As the units passed all testing, the actual root cause cannot be identified.A potential root cause could be, in the case of the unit that did not function during use, this may have been caused by a leaking vessel, a fill spout at the rear of the vessel not closed fully or a leak between the junction of the patient tube on the vessel and thoracic catheter.A failure investigation has been opened.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 this lot.Based on the above, no further action is required at this time.

• Brand Name: ARGYLE ALTITUDE DRY SUCT 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: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4853653
• MDR Text Key: 5872207
• Report Number: 9611018-2015-00003
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 14L020FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1