MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number BO-VKMO 11000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital: "we had no trouble priming the circuit (ie.No evidence of high pressure etc.)however with the initiation of bypass, venous return was very limited.A second cannula was placed in the ra with no change in venous return.We had to change the reservoir (and membrane) prior to commencing with bypass.We flushed out the reservoir, no clots are visible.It does seem to fill slower than normal when we try to "re-prime" the reservoir.Dr.(b)(6) it had nothing to do with cannula position." (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) received the product for investigation.A vhk 11000 was sent back.During the visual inspection, a wrong/foreign screw cap was screwed to the blood inlet connector of the nodop-clear luer connection.The cone of the screw cap is not round.All other connections were open.During filling reservoir, sample dripped at the nodop-clear luer connection.The foreign screw cap was replaced.No more drop were observed.The reservoir could be filled properly.All connections were closed and connected the water tube at the inlet to adjust a water circuit.No abnormalities were detected.The available information was shared internally with getinge therapy application manager.It was stated that; "the response from the clinical site does not reveal any shortcomings in terms of application of the device.The retrieved investigation report implies that the applied procedure during the test may not have adequately reflected the found malfunction from the site of operation.The test result with water may not sufficient to identify the claimed device restriction.With the current data there is no final assessment possible.A device malfunction cannot entirely ruled out." also according to the received information from the laboratory upon the comments from getinge therapy application manager, it is not possible to confirm the failure.Based on this complaint could not be confirmed.Device history record shows no abnormality.No similar complaint was found.Also no systemic issue was determined.This complaint is now closed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.

Event Description

(b)(4).

• Brand Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• 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: 6856136
• MDR Text Key: 85938610
• Report Number: 8010762-2017-00290
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Model Number: BO-VKMO 11000
• Device Catalogue Number: 701053444
• Device Lot Number: 92218708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Date Device Manufactured: 02/01/2017
• 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