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

Model Number VKMO 78000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Jan 25, 2016 10:28 am (gmt-5:00) added by (b)(6): (b)(4).The device has been requested for return; but not yet received.A supplemental medwatch will be submitted when additional information becomes available.Additional information: the product mentioned is a vkmo and the included affected component has the contributing design function of the quadrox-i which is registered under 510(k): k082117.

Event Description

When customer opened the package they noticed that the blood outlet connector was broken off.(b)(4).

Manufacturer Narrative

02/26/2016 10:48 am (gmt-5:00) added by (b)(4): the device history record of the reported lot has been reviewed by maquet cardiopulmonary medikal teknik san.Tic.Ltd.Sti.With no abnormality was found.The investigation showed that the reported lot was a rework lot.Although, total set order was (b)(4), only 2 of them had been reworked.The rework was related to damaged boxes.The outer boxes were changed and the products inside were not checked by maquet cardiopulmonary medikal teknik san.Tic.Ltd.Sti.If the outlet connector was broken during production the damage would have been noticed.The manufacturer`s review of the quality control process indicated that a 100% functional and visual inspection 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 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.

Event Description

(b)(4).

Manufacturer Narrative

Attempts for the sample to be returned were made but the sample was not received and therefore it was not possible for a full investigation to be performed.Based on the available information, a definitive root cause cannot be determined, but the most probable cause is considered to be damage during transport.No health risk or patient impact has been identified.No systemic issue was identified from the complaint database review but the data however, will continue to be monitored and 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 or action is warranted at this time and the complaint will be closed.Note: the customer's reported issue was reported initially on the basis of a previous mdr (b)(4) for a similar issue.However, according to current internal processes and external regulations, the issue observed by the customer in both complaints does not represent a reportable event, as the issue was detected on opening the packaging thus excluding the product from patient use.Going forward, such cases will not be reported to the competent authorities.This is the final report.

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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5390001
• MDR Text Key: 37033842
• Report Number: 8010762-2016-00039
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082117
• 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,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• 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: 70106.4525
• Device Lot Number: 92139022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Date Device Manufactured: 06/01/2014
• 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