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

Model Number PVL 2555#HLS CANNULA 25F VENOUS LONG

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

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that there was a hole in the internal (sterile) packaging hls cannula.The product was not used on a patient even the hole was small but it renders the cannula unsterile.Complaint #: (b)(4).

Manufacturer Narrative

The investigation is still ongoing.A follow-up medwatch will be submitted when further information becomes available.

Manufacturer Narrative

It was reported that there was a hole in the internal (sterile) packaging hls cannula.The product was not used on a patient even the hole was small but it renders the cannula unsterile.No harm to any person was reported.The affected cannula was investigated with the photograph provided by customer.The hole in the medical paper of the sterile packaging is visible.The holes in a primary packaging could cause non-sterility of the product.Based on this the reported failure 'hole in the sterile packaging' could be confirmed.The root causes of the reported failure 'hole in the sterile packaging' was determined to be as follows: - packaging design.Maquet cardiopulmonary has already initiated a corrective action within the capa process in order to improve the design to prevent such packaging damage in the future.The affected product was produced before the corrective action was implemented.The corrective action contains of implementation of primary packaging of hls cannulae from medical paper to tyvek of hls cannula.The production history record (dhr) of the affected pvl 2555#hls cannula 25f venous long with lot#92293468 was reviewed.According to the dhr results, the product pvl 2555#hls cannula 25f venous long passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: CANNULA & CATHETER
• 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: 13888507
• MDR Text Key: 287826586
• Report Number: 8010762-2022-00100
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: PVL 2555#HLS CANNULA 25F VENOUS LONG
• Device Catalogue Number: 701047271
• Device Lot Number: 92293468
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1