MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HQV 33800#COMPLETE PACK; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number BE-00175

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary ag is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been tested.The tested products has the same leakage at the same position.This could be determined as bonding failure.Visual inspection, tightness test acc.To lv 203 and tightness test with roller pump have been performed.Results: during tightness test acc.To lv 203 the exact position of the leak in the arterial filter between the cover and the housing could be detected (improper ultrasonic welding).During testing with roller pump leakage at quart could also be detected but the exact position was not found during this kind of test.The existing liquid collected at the lowest point of the filter and drained.Most possible root cause could be the bad bonding between cover and filter body.The data is also 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

It was reported that prime a leak occurred at by opening the bypass.No known consequences to the patient were reported.(b)(4).

• Brand Name: BE-HQV 33800#COMPLETE PACK
• 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: 5972617
• MDR Text Key: 55794700
• Report Number: 8010762-2016-00588
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K090518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2016

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: 05/01/2018
• Device Model Number: BE-00175
• Device Catalogue Number: 701002503
• Device Lot Number: 92189712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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