MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY QUADROX-I + HMO 70000+VHK7100; VKMO 70000 #QUADROX-I HMO 70000+VHK7100

Model Number 70106.4523

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2014

Event Type  Injury  

Event Description

It was reported that during a routine cabg case, the surgeon placed a double stage cannula.Bypass was initiated.The venous clamp was opened as normal, but had very poor return.The cannula position was checked, but nothing changed.The decision was made to change the cannula.Prior to connecting the venous line to the new cannula, the clamp was released to see if there was air return but air return remained poor.It was assumed that the problem was with the reservoir, an obstruction or a filter problem.The vent ports (yellow caps) were off, act was 524 seconds.The entire system- reservoir and oxygenator were changed and all was fine.There was no reported pt effect.Ref.#: (b)(4); cabg- coronary artery bypass graft.

Manufacturer Narrative

The device has not been returned yet for eval.A supplemental medwatch will be sent when additional info becomes available.

• Brand Name: QUADROX-I + HMO 70000+VHK7100
• Type of Device: VKMO 70000 #QUADROX-I HMO 70000+VHK7100
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4425605
• MDR Text Key: 5413440
• Report Number: 8010762-2015-00006
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2014

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: 07/01/2016
• Device Model Number: 70106.4523
• Device Lot Number: 92145578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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