MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BO-HQV 49500#COMPLETE PACK, ADULT

Device Problem Leak/Splash (1354)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The complaint was received from netherlands.It was reported that there was a leakage from cdi cell and the failure was detected during perfusionist run.The operation was successfully completed with the pack.No actual harm or death was reported.Complaint# (b)(4).

Manufacturer Narrative

It was reported that there was a leakage from cdi cell and the failure was detected during perfusionist run.The operation was successfully completed with the pack.No harm to any person has been reported.The product was investigated in getinge laboratory on 2022-03-15 with following outcome: the leakage was occurred on approximately 1.4 - 1.4175 bar.According to instruction for use of hlm tubing sets pressure in the circuit exceeding 1.000 mmhg (133.3 kpa - 1.3 bar) or below -150 mmhg (-20 kpa - -0.2 bar) may cause leaks or damage to the device.Since the leakage was occurred at 1.4 bar and no damages could be detected on either cdi cell nor tube, there could not be found any product malfunction.Based on the test results, the reported failure could not be reproduced or confirmed.The production history record (dhr) of the affected bo-hqv 49500#complete pack, adult with lot# 3000178908 was reviewed on 2022-03-07.According to the dhr results, the product bo-hqv 49500#complete pack, adult passed the defined manufacturing and final release specifications.Thus production related influences are unlikely.The getinge sales and service unit will be informed about the investigation results to communicate to the customer.However, the reported failure leakage could be linked to the risk assessment and control tubing sets (dms#(b)(4), v20) and the most probable root causes are: - use errors: lack of attention.- lack of information on permissible pressure values.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.

Event Description

Complaint (b)(4).

• Brand Name: TUBING SETS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 13025329
• MDR Text Key: 282393718
• Report Number: 8010762-2021-00662
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K090533
• 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: 03/25/2022

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: 06/25/2023
• Device Model Number: BO-HQV 49500#COMPLETE PACK, ADULT
• Device Catalogue Number: 701076376
• Device Lot Number: 3000178908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose