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

Model Number BO-HLS 7050-CA

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

November 16, 2015 11:46 am (gmt-5:00) added by (b)(6): (b)(4).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 (fsca # 2014-12-11).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 on ecmo with beq hls 7050ca since (b)(6), developed a hitt and was switched to bo hls 7050 on (b)(6).On (b)(6) they noticed a blood leak at the exhaust port under the oxygenator.They switched out the circuit to another bo hls 7050.No consequence for the patient.Blood loss about 100ml.Leakage took place around 12-16 hours as they were ensuring that the condition of the patient was stable to change out the circuit." (b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE 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: 5227222
• MDR Text Key: 31322209
• Report Number: 8010762-2015-01172
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Notification
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: BO-HLS 7050-CA
• Device Catalogue Number: 70106.7424
• Device Lot Number: 70100366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 8010762-02/18/2015-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention