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

Model Number BO-HQV 59203

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

November 16, 2015 02:08 pm (gmt-5:00) added by (b)(6): (b)(4).Maquet cardiopulmonary (b)(4) is aware of similar complaints from this product.These similar products, showing a similar malfunction, have been tested and during a tightness test, a leakage from the de-airing port could be confirmed.The manufacturer determined so far that the de-airing membrane becomes permeable for fluids (priming solution / blood).The investigated customer complaints showed nonconforming areas in the membrane body as well as week bonding between the membrane and oxygenator as most probable cause.Determining the root cause is still under investigation.Therefore maquet cardiopulmonary (b)(4) has initiated a capa process (capa-(b)(4)) to address the appropriate corrective and preventive action.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Description from the complaint report: "oxygenator primed and bypass initiated.Noticed leak on the venous side air vent port.Plugged it with a cap and finished procedure.Oxy being sent for investigation." (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) is aware of similar complaints showing a similar malfunction.These products have been tested and during tightness test, a leakage from the de-airing port could be confirmed.Therefore maquet cardiopulmonary (b)(4) has initiated a capa process to address the appropriate corrective and preventive action.Every oxygenator - produced by maquet (b)(4) - possesses a de-airing port located at the blood inlet side of the device.For this purpose a hydrophobic pfte (poly-tetra-fluoro-ethylene) membrane, which is laminated on a polyester fleece, is welded on a de-airing connector.This combination is fixed to the oxygenator by gluing.Due to leakage of liquids through the de airing membrane, both the number of customer complaints and the oxygenator production failure rate, increased considerably during the last years, particularly since 2013.Up to date investigation actions continue, however some findings are already available.Experiments could demonstrate that rough handling during welding as well as poor storage of the de-airing connectors can result in leakage.The first measure against leakage is already taken by manufacturing stackable storage boxes with cavities for 150 de-airing connectors in each case.The new storage boxes are utilized since 2016-02-01.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

Result of the root cause analysis: meanwhile the root cause as identified.Investigations could prove that the introduction of the new glue for adult and small adult oxygenators at the beginning of 2013 - is not responsible for the increased leakage of de-airing connectors.The root cause comprises the following three sub items: the laminated ptfe membrane shows qualitative differences within the lot due to the size of the production lot (minimum 1850 feet x 11.25 inch) and the packaging of the rolls.The functional ptfe membrane is very sensitive to mechanical stress.Therefore the hitherto existing instructions in bop (basic operation procedure) 714 for punching and bop 715 for welding the de-airing membrane will be adjusted.The softline coating and the pressure test of oxygenators takes place simultaneously at 1.1 bar.The hydrophobic character of the membrane is changed by dint of the hydrophilic softline coating solution, which enters into the ptfe membrane.

Event Description

(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): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5227310
• MDR Text Key: 31329706
• Report Number: 8010762-2015-01174
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102464
• 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,Followup,Followup
• 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-HQV 59203
• Device Catalogue Number: 70105.2098
• Device Lot Number: 92167988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention