MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number P-0400#HEMOCONCENTRATOR SET INCL. BC 140

Device Problem Leak/Splash (1354)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The blood spilled over the membrane onto the plasma side (filtrate side).It occurred during patient use.No actual harm or death.Complaint #: (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the blood spilled over the membrane onto the plasma side (filtrate side) of bc 140 plus.It occurred during patient use.The customer change the product and used a new one.No harm to any person was reported.The product was investigated in the getinge laboratory.A hemoconcentrator bc 140 was delivered.On the filtrate side of the hemoconcentrator, blood residues between the fibres could be confirmed.No damaged or loose fibres could be detected from the outside.Based on the investigation the failure can be confirmed.The bc140 is produced at an external supplier.Therefore, for further investigation scar was initiated.The supplier was informed about this complaint and scar.If significant information becomes available, we will initiate further steps.More information was requested in regards to the pressure values, blood and filtrate flow values.However, getinge representative confirmed that the customer can no longer answer our questions and the team of perfusionists is very experienced and uses this hemoconcentrator very often and so far they have not had any failures.The production history record (dhr) of the affected p-0400# with lot # 3000235012 was reviewed.According to the dhr results, the product p-0400# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The exact cause of the failure could not be determined.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.

• Brand Name: HEMOCONCENTRATOR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 16654750
• MDR Text Key: 312507270
• Report Number: 8010762-2023-00157
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Model Number: P-0400#HEMOCONCENTRATOR SET INCL. BC 140
• Device Catalogue Number: 701005142
• Device Lot Number: 3000235012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1