MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA

Device Problems Break (1069); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2016 10:02 am (gmt-5:00) added by (b)(6).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4) (b)(6).The device has not yet been received for investigation.A supplemental medwatch will be submitted when additional information is received.

Event Description

On (b)(6) 2016 09:56 am (gmt-5:00) added by (b)(6).Description from the customer report: "this is out of box.The arterial connection port was broken off oxygenator.Product did not reach patient." (b)(4).

Manufacturer Narrative

Based on the received failure description and the picture provided by the customer the reported failure could be confirmed.The device history record for the related product has been reviewed by maquet (b)(4).The product passed every production step and was not marked as scrap.During the review of the dhr / avz no production parameters could be identified that would indicate a nonconformance during production, in regards to the reported failure.The manufacturer`s review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damage found on the product are due to excessive external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.

Event Description

(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE
• 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: 5488923
• MDR Text Key: 40308653
• Report Number: 8010762-2016-00161
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100278
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701050330
• Device Lot Number: 70102417
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Date Device Manufactured: 11/01/2014
• 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