MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH RESERVOIR; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number VKMO 78000

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that getinge china quality assurance found a report about vkmo 78000 from china national medical product administ adverse reaction monitoring system.It was reported that the customer noticed a big tear on reservoir before using it.The customer used a sterile flim to stick on it and continued to treat the patient with the vkmo.No harm or death was reported.The sample investigation could not be performed since the sample could not be provided due to the chinese customs restrictions and regulations.However, a photograph was received from customer which shows the broken connection to oxygenator part of reservoir.The failure was found prior to use and the customer had to use a sterile flim to stick on it.The failure could be confirmed.The production history record (dhr) of the affected vkmo 78000 with lot # 3000307710 was reviewed.According to the dhr results, the product vkmo 78000 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.The broken part is connection to oxygenator part of reservoir is controlled in accordance with basic operation procedure (bop) 9203520 ¿connection with oxygenator¿ rev.03.There is 100% control to ensure the connection clips of oxygenator and reservoir are engaged completely.Besides there is another 100% visual control for cracks on the assembled reservoir.Taking into consideration of the connection cannot be made if there is break at the connection to oxygenator part of reservoir, the production related influences are unlikely.The reported failure was identified as part of the current risk management file and the most probable causes are associated to: user: - user unable to fixate reservoir appropriately - reservoir is fixated insecurely and falls down logistics: - mechanical damage of product the risk is mitigated with below ifu (instruction for use) warnings: ¿¿ do not use the device if it or the sterile packaging is damaged.¿ (ifu venous hardshell cardiotomy reservoir vhk 70000 / vhk 71000, g-159, v08, page 9) ¿perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fractures.¿ (ifu venous hardshell cardiotomy reservoir vhk 70000 / vhk 71000, g-159, v08, page 14) the occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : 4115.

Event Description

It was reported that getinge china qa found a report about vkmo 78000 from china national medical product administ adverse reaction monitoring system.It was reported that they noticed a big tear on it before using it, theb they used a sterile flim to stick on it and continued to treat the patient with the vkmo.Complaint #: (b)(4).

• Brand Name: RESERVOIR
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17680783
• MDR Text Key: 323213527
• Report Number: 8010762-2023-00443
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 78000
• Device Catalogue Number: 701067941
• Device Lot Number: 3000307710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1