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

Model Number BEQ-HMOD70000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was discarded by the hospital; therefore no manufacturer laboratory investigation was possible.Several attempts were performed to obtain the oxygenators serial number for a dhr review, those attempts were not successful, therefore a dhr review of the product in question was not possible.A review for similar complaints was performed.The investigation results out of a similar complaint were as follows: the product was tested and was operating within the manufacturer's specifications.No clotting was observed.A dhr review was performed, no abnormalities were detected.A sap trend search was performed for hmod 70000, failure code: clotting, with the following outcome: 11 complaints were found since 10/2011.All of them are closed.Due to this information no systemic issue could be determined.Clotting is a known phenomenon and has been investigated in a previous complaint.The cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in operated within maquet cardiopulmonary specifications.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.

Event Description

According to the customer: i was made aware of this event on(b)(6) 2016.The customer stated that during (b)(6) 2016 a patient placed on support using a beq-hmod70000 required four change-outs to new oxygenators in the course of support.The customer stated that the patient required a heparin dosing of 6000 iu/hr maintaining acts of 192-208 secs.The customer stated that of the four oxygenators used, one hmod70000 clotted within 12 hrs of placement with no decrease in gas transfer or performance.No adverse effects were reported with respect to the patient.The product was not retained for inspection.(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, 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: 5990975
• MDR Text Key: 56802094
• Report Number: 8010762-2016-00600
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000
• Device Catalogue Number: 701053824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• 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
• Patient Age: 36