MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number VKMO 71000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

"y connector coming out of outlet side of oxygenator was leaking.The perfusionist replaced the part.No harm to patient, piece was changed out, piece is available for evaluation if necessary." (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product back for investigation.As a complaint sample, one y-konnektor (jostra 1/4¿x1/4¿x1/4¿) was received.The connector was cleaned with sodium hypochlorite and disinfected with incidin liquid.Visual inspection and leak test with water was performed.During the optical examination of the y connector, a crack was found in the connector.During a leak test with water, water leaked from this crack.Getinge cp antalya site investigated the issue.It is concluded, when related pictures are compared, that there is an nc(non-conformity) record (b)(4) for this issue and product.According to nc: the 701021414 y connector in a tube set undergoing lal test was found to be broken.When the fracture surface was examined, it was seen that the connector, which should have a ductile structure, was of a brittle structure.The material of the connector is pctc.A total of 17 broken connectors were recorded from lots 19-9201768 and 19-9201769 with the same supplier lot since the day the error was detected.As an action scar (supplier corrective action) (b)(4) has been initiated regarding this nc.According to supplier: the root cause is defined with 5 why method and found tool related demoulding.As an action, supplier reported that two additional cooling circuits were connected including cooling time opritmization from 20 sec.To 25 sec.Device history records were reviewed.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.One damage box rework record was found for reported lot number 92284996 which is performed on 2019-october at xpo warehouse for the one piece of product.However, it is unlikely to detect whether the product is also damaged or not.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.According to bop (basic operation procedure) 9201211 revision 02, the connector and tube are checked 100% visually before and after the process regarding scratch and dents.During incoming inspection the controls regarding material scratchings and damages are performed based on sampling method per ri-215 revision 02.The reported failure was identified as part of the current risk management file (b)(4) and the most possible root causes are associated to material failure from the supplier and mechanical damage on product exerted after release.Mitigations for this specific failure are in place as per manufacturing procedures and in ifu (instruction for use) in order to reduce of similar failures during the manufacturing process and during use.Based on the information obtained so far within this investigation, the exact cause of the failure could not be identified.The most probable causes could be found as: supplier - material failure related with supplier - trend search shows similar issues from the same batch.Transport & handling - excessive physical force on the product - there is damage box rework record which was performed before the date this lot has been released to customer.Based on this, failure could be confirmed.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Complaint: # (b)(4).

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9705287
• MDR Text Key: 192166743
• Report Number: 8010762-2020-00057
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: VKMO 71000
• Device Catalogue Number: 70106.7949
• Device Lot Number: 92284996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 03/30/2020
• Patient Sequence Number: 1