MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VENOUS HARDSHELL CARDIOTOMY RESERVOIR; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 78000

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital:"there was leakage from the one-way valve.So the perfusionist exchanged another set." (b)(4).

Manufacturer Narrative

A review of the device history record was performed with no abnormality found.A sap trend search was performed for 70106.4525, failure code 0114 other tube set components and two additional complaint was found which has been already closed.(b)(4) requested the product for investigation but the product was not available.Therefore no laboratory investigation could be performed by the manufacturer.Although the product was not received, the investigation was performed based on the similar complaint (b)(4) laboratory investigation results.Based on the visual inspection and the leak test of the (b)(4) complaint sample, a crack was detected at the one-way valve.This failure was confirmed by the laboratory.Based on this information, the failure could be confirmed.The most probable cause of the failure is found as material failure.As a corrective action, (b)(4) was opened and all actions will be followed by (b)(4).The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIR
• 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: 6824273
• MDR Text Key: 83960067
• Report Number: 8010762-2017-00278
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141432
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: VKMO 78000
• Device Catalogue Number: 701064525
• Device Lot Number: 92217112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Date Device Manufactured: 11/01/2016
• 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