MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701044054

Device Problems Failure to Prime (1492); Device Inoperable (1663); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

On 02/26/2016 10:30 am (gmt-5:00) added by (b)(6): (b)(4).A maquet field service technician will investigate the unit.A supplemental medwatch will be submitted as soon as additional information becomes available.

Event Description

On 02/26/2016 10:22 am (gmt-5:00) added by (b)(6): it was reported; "water was changed during normal user maintenance.The day after the clinic should use the machine when they got a "low flow alarm" on the cardioplegia side.The unit is working when it is set to maximum cooling but when heating they will get the low flow alarm and there is a "air in the water" noise.Then the pump stops." additional information: the error occurred during priming / setup, no patient was involved.(b)(4).

Manufacturer Narrative

The device was investigated by a maquet technician based in (b)(4).The technician confirmed that no parts were replaced.He found that the shunt valve could not close due to a piece of plastic glove that was stuck in the shunt valve.The piece of the plastic glove was removed, the shunt valve was remounted onto the device and all controls performed were deemed compliant.

Event Description

(b)(4).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5466621
• MDR Text Key: 39643950
• Report Number: 8010762-2016-00124
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701044054
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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