MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-PLS 2051

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 12:16 pm (gmt-5:00) added by (b)(6) ((b)(4)): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).Maquet is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been tested and under optical microscope delamination of some gas fibers were observed.Hence, the priming solution or blood was able to flow inside the gap between the gas fibers and polyurethane and the gravity guided it to the gas exiting path along the housing.The manufacturer initiated a customer notification concerning the problem, the potential risk and the recommended handling in the event this failure occurs (fsca (b)(4)) the investigation under capa process (capa (b)(4)) has identified that the root cause is due to the manufacturing process of the raw material fibers used in the oxygenator.If, during the surface pre-treatment, a system malfunction results in a system stop, the entire length of the fiber is not properly treated to modify the surface tension.If these untreated fibers are present in the epoxy area of the oxygenator, it is not properly fixed in the epoxy.When this occurs, the fibers are able to ¿shrink out¿ of the epoxy and result in the reported leakage.The raw material manufacturer has initiated steps to repeat the surface pre-treatment to ensure that the proper surface tension is present on the entire length of the fibers.

Event Description

Description from the customer report: "patient placed on to femoral veno arterial ecmo post cardiac surgery.On initiation of ecmo (= extracorporeal membrane oxygenation) blood noted immediately dripping under oxygenator on to floor.On closer inspection blood was dripping from gas outlet of quadrox oxygenator.The decision was made to change the circuit as a matter of safe practice.This procedure was done with no complications and the pls 2051 ecmo set was then unfortunately discarded before a lot number could be retrieved.It was estimated that during the initial patient support with leaking oxygenator to when the circuit was changed out that approximately 5 mls of blood loss occurred to the patient from the gas outlet of oxygenator.There was no adverse outcome as a consequence of the circuit changeout to the patient." (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5290743
• MDR Text Key: 33348651
• Report Number: 8010762-2015-01229
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: BE-PLS 2051
• Device Catalogue Number: 70105.0310
• Device Lot Number: 70102841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/11/2015
• Date Device Manufactured: 02/01/2015
• 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): Required Intervention
• Patient Age: 57 YR