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

Model Number BO-HBF 140-J

Device Problem Leak/Splash (1354)

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

Event Date 03/04/2018

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 hospital: "during priming for a emergency surgery, it was found that the priming solution was leaking from around the bypass valve at the lower part of the device.Replaced the device from the same lot to continue the procedure." no known consequences to the patient was reported.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).Maquet cardiopulmonary (b)(4) is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been tested with complaint (b)(4).Maquet cardiopulmonary (b)(4) received the product back for manufacturer investigation.During laboratory investigation a tightness test was performed.Thereby a leakage between housing and cover has been detected at the quart filter.Therefore the reported leakage could be confirmed.The failure is already known to the manufacturer and has been thoroughly investigated.The most possible root cause is the bad bonding between housing and the cover of the quart filter.Based on this no further action will be completed at this time.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• 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: 7365435
• MDR Text Key: 103530160
• Report Number: 8010762-2018-00106
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: BO-HBF 140-J
• Device Catalogue Number: 701048784
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1