MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 78000

Device Problems Break (1069); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product was received for evaluation under complaint # (b)(4).During this investigation in addition it was found that cracks on luer lock on arterial connector of the oxygenator occurred.This additional complaint was opened to evaluate this failure.No evidence was provided that this failure was noticed within the initial complaint report.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 damages found on the product are due to excessive or inadequate 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.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.(b)(4).Additional information: the product mentioned is a vkmo and the included affected component has the contributing design function of the quadrox-i adult which is registered under 510(k): k082117.

Event Description

During investigation of complaint (b)(4), an additional malfunction (cracks on luer lock on the arterial connector) were found.(b)(4).

Manufacturer Narrative

For further investigation a device history record of the complained product has been reviewed by the manufacturer.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 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.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• 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: 5701909
• MDR Text Key: 47894286
• Report Number: 8010762-2016-00370
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: VKMO 78000
• Device Catalogue Number: 701064525
• Device Lot Number: 92144502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1