MAUDE Adverse Event Report: TELEFLEX MEDICAL INCORPORATED PLEUR EVAC; BOTTLE, COLLECTION, VACUUM

Model Number IPN010586

Device Problems Air Leak (1008); Failure to Run on Battery (1466); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Event Description

Patient had thoracic surgery requiring 2 chest tubes attached to two drainage sets (that were placed in the thoracic or).The patient is now ambulating connected to a portable suction set-up(s) on the thoracic post-op floor x 2 days now.The patient's drainage systems continue to have persistent "air leaks" in her chest tubes.Today the rn hooked up her portable suction to the pleur_evac dry chest drainage systems (that are currently replacing our atrium system.) the suction did not register in the "meter indicator" we tried different portable suction machines and the portable suction could not make the suction meter register as "on".This was not a problem when placed to wall suction.The nurses changed out her chest drainage system to the atrium oasis system and the portable suction worked effectively.Manufacturer response for pleur-evac, single collection chamber 2500ml (per site reporter): our materials management department will be made aware and will reach out to the company representatives.(b)(4).

• Brand Name: PLEUR EVAC
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6328409
• MDR Text Key: 67565497
• Report Number: 6328409
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN010586
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 220002789 R03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PORTABLE SUCTION UNITS X2
• Patient Age: 68 YR
• Patient Weight: 68