MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VKMO 78000; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number 701064525

Device Problem Break (1069)

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted if additional information becomes available.Additional information: the product mentioned is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510(k): k102919.

Event Description

It was reported that during patient treatment, the side connection on the inlet of the reservoir (temperature probe) was broken down.The reservoir had to be replaced during treatment - no severe delay for the treatment.No known consequences to the patient.(b)(4).

Manufacturer Narrative

The result of our analysis of this complaint from (b)(6): the probable root causes could be determined as a material failure and design failure.Device history records of the complained lot has been reviewed and no abnormality was found for the related material.Moreover, no scrap record for the related material was found.The crack on the temperature probe could be related with weakness of the material.On the other hand, it could be possible that the operator could tighten the temperature probe regardless of the torque settings.Thus, basic operation procedure related with the torque values should be revised.As a corrective action, for the previous complaints regarding to the same failure, we had opened capa (b)(4) and all actions will be followed by capa (b)(4).Also, our operators have been informed with regard of the complaint.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

(b)(4).

• Brand Name: VKMO 78000
• 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: 5637041
• MDR Text Key: 45039675
• Report Number: 8010762-2016-00320
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 701064525
• Device Lot Number: 92159713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• Date Device Manufactured: 01/01/2015
• 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