MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 71000-USA

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

According to the customer: "chief of perfusion was setting up his pump for the day.He opened the box of the vkmo 71000 oxygenator and reservoir.When he removed the components from the package he noticed that there was a red mark on the plastic bag and evidence of a drop.As he removed the oxygenator and reservoir he noticed damage to the arterial outlet.The arterial outlet was actually broken off." (b)(4).

Manufacturer Narrative

The product in question was not yet returned to the mfr.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.Additional information: the product mentioned under section d is a set and the included affected component has the contributing design function of the quadrox-i which is registered under (b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.The outer (primary and secondary) packaging of the product was visually inspected and several damages were found.Also damages were detected at the quadrox-i and the vhk.The blood outlet connector was broken and deformed.The glued connection of the connector was not affected.The failure "arterial outlet was broken off" could be confirmed.Furthermore damages at the reservoir (blue welding point broken within reservoir/ temperature connector several small cracks at thread) were detected.An additional complaint will be opened in order to cover these failures.The side caps of the oxygenator and reservoir were damaged as well.The most probable cause of the failures found is excessive physical force during transport.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4931021
• MDR Text Key: 6052814
• Report Number: 8010762-2015-00825
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: VKMO 71000-USA
• Device Catalogue Number: 70106.4568
• Device Lot Number: 92143679
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1