MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VAVD CONTROLLLER; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number VAVD CONTROLLER

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 11:35 am (gmt-4:00) added by (b)(6): (b)(4) the device has been requested for return numerous times.Additional information pertaining to the incident has also been requested but not received.It is not clear if the incident occurred during patient therapy.If the issue took place during patient treatment, a serious injury could occur due to air being in the system.A supplemental medwatch will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported the device appeared to generate more negative pressure than the gauge indicated.The gauge would not read zero when the vacuum source was removed from the controller.Air was generated in the circuit.It was understood that this experience is due to excessively high negative pressure generated by the device.It was not reported whether this experience occurred during a patient procedure or during set up.(b)(4).

• Brand Name: VAVD CONTROLLLER
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5024755
• MDR Text Key: 23831486
• Report Number: 8010762-2015-01009
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAVD CONTROLLER
• Device Catalogue Number: 70103.5905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Date Manufacturer Received: 07/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention