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

Model Number BE-HLS 7050

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 12:16 pm (gmt-4:00) added by (b)(6): maquet cardiopulmonary 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 (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.Additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

Event Description

Description from the customer report: patient placed onto ecmo via cardiohelp hls system.Immediately noted slow drip of blood from gas outlet of module.Patient was transported to managing facility without incident and blood leak still noted.Decision was made to change out circuit for safety concern.Circuit changed out without incident.(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: 5068409
• MDR Text Key: 25446539
• Report Number: 8010762-2015-01041
• 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
• Remedial Action: Other
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 70104.7753
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• 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