MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ARTERIELLER FILTER QUART; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number BO-HBF 140-J

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: "during the leak test (@100kpa) , the leakage was detected on 2 products." no known consequences to the patient was reported.(b)(4).

Event Description

Ref.: # (b)(4).Customer ref: # (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).The product has been received at maquet for investigation.According to the investigation report following tests have been performed: leak test and test with connection to water cycle incl.Flow- and pressure-measurement.During both tests 2 leakages at the connection of the housing and the cover were detected: leaking point at the de-airing port and at the white bypass port.Thus the failure could be confirmed.Most possible root cause could be determined as bad welding between cover and housing of the quart filter.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.

• Brand Name: ARTERIELLER FILTER QUART
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7965434
• MDR Text Key: 123948572
• Report Number: 8010762-2018-00279
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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 Model Number: BO-HBF 140-J
• Device Catalogue Number: 701048784
• Device Lot Number: 70122712
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1