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

Model Number BE-HQV 33800#

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

November 06, 2015 11:33 am (gmt-5:00) added by (b)(6): (b)(4).Maquet cardiopulmonary (b)(4) is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been tested.We tested a reserve 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 "during ecc, a leak occurred along side of quart arterial filter.The blood loss was less then 10cc.They exchanged the quart by a spare one i had given them in case of defect." no known consequences to the patient.(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): 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: 5209448
• MDR Text Key: 30692644
• Report Number: 8010762-2015-01148
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HQV 33800#
• Device Catalogue Number: 70101.8883
• Device Lot Number: 92179760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/07/2015
• Date Device Manufactured: 07/01/2015
• 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
• Patient Outcome(s): Required Intervention