MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HLS SET

Device Problems Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the customer states he received 4-hls sets and one of the set has a puncture in the tyvek.The failure occurred before use.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the customer states he received 4-hls sets and one of the set has a puncture in the tyvek.The failure occurred before use.The affected product was investigated by the getinge laboratory on 2023-12-14 with following conclusion: the failure could be confirmed.The most probable root cause is a load on the brown shipping carton (outer packaging) on the opening side, most likely due to improper stacking.The result was a damage of the tyvek cover.The getinge global sales qrc was informed that improper stacking of future product shipments could be prevented by optimizing the work instruction.The affected product has been reviewed for the reported failure on 2023-12-05.According to the final test results, the hls set passed the tests as per specifications.Based on the results the reported failure "punctured tyvek" could be confirmed, but was no product related malfunction.The customer will be informed about the results by the getinge sales and service unit.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: TUBING SET
• Type of Device: OXYGENATOR, 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: 17773067
• MDR Text Key: 323720376
• Report Number: 8010762-2023-00466
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000330095
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1