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

Model Number HQV 51202

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that customer received a damaged pack and the damage was detected on tyvek as a hole.The product was not used for treatment.No harm to any person was reported.

• Brand Name: TUBING SETS
• Type of Device: TUBING, PUMP, 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: 18649174
• MDR Text Key: 334656006
• Report Number: 8010762-2024-00071
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053025
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HQV 51202
• Device Catalogue Number: 701032773
• Device Lot Number: 3000348883
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other