MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BO-H 92101#CIRCUITO CEC; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number BO-H 92101

Device Problem Leak/Splash (1354)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet (b)(4) is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been tested.We tested the returned filter in our laboratory, following our standard process, on tightness.Therefore, the quart was tested at below water in a water bath and was then pressurized with compressed air (0.3 bar).Due to the air escaping (visible as air bubbles in water) a leakage in the welding cover has been found.The leakage at the connection between cover and filter body can be confirmed.Most possible root cause could be the bad welding between cover and filter body.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.

Event Description

Customer reported that "priming leakage from the filter lower section (by-pass selector area)." no known consequences to the patient.(b)(4).

• Brand Name: BO-H 92101#CIRCUITO CEC
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5294932
• MDR Text Key: 34134684
• Report Number: 8010762-2015-01249
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K001787
• 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
• Report Date: 11/30/2015

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-H 92101
• Device Catalogue Number: 70106.8671
• Device Lot Number: 92181373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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