MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-PLS 2050 # PERMANENT LIFE SUPPORT SET; DIFFUSION MEMBRANE OXYGENATOR/BE-PLS 205

Catalog Number 70105.0758

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 08/18/2014

Event Type  Death  

Event Description

It was reported that leakage was detected at the gas outlet port one hour after ecmo (extra corporeal membrane oxygenation) was initiated and continued for 60 hours.Bubbles were initially observed after 20 hours and increased leakage after 40 hours.A total of 2000 ml of blood were confirmed to have leaked.Gas flow was 3.5-3.8 1/min.The device was not swapped out at the request of the family.The pt expired after 60 hours of therapy.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary is aware of similar complaints.The devices displayed a similar malfunction which were tested and evaluated under an optical microscope.Delamination of some gas fibers was observed which allowed for the priming solution or blood to flow inside the gap between the gas fibers and polyurethane.Gravity then allowed for passage to the gas exiting path along the housing.The most probable root-cause is the delamination of the hollow gas fibers from the polyurethane potting area.A review of the quality control process confirms that 100% functional inspection for leakage is performed during production.Maquet cardiopulmonary ag has initiated an internal process ((b)(4)) to address the appropriate corrective and preventive action.A supplemental medwatch will be submitted when additional info becomes available.

• Brand Name: BE-PLS 2050 # PERMANENT LIFE SUPPORT SET
• Type of Device: DIFFUSION MEMBRANE OXYGENATOR/BE-PLS 205
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice krebs ; 45 barbour poind dr; wayne, NJ 07470 ; 9737097359
• MDR Report Key: 4112810
• MDR Text Key: 4702420
• Report Number: 8010762-2014-00339
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2014,08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 70105.0758
• Device Lot Number: 70098771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR