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

Model Number BO-HBF 140-J

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet getinge group 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.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is an systemic error.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

As stated by the customer: "when leak check(100kpa) at the product inspection, they found the failure and gave the sink test to make sure the leak point.No adverse effect to the patient.Incident occurred before patient use." (b)(4).

Manufacturer Narrative

Maquet medical systems,usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: e2018002.Importer: (b)(4).Contact person: (b)(6).Correction: correction- it was noted that during an internal review the aware date on the draft initial mw from the factory was 12/22/2017; whereas the aware date noted on the initial trackwise submission was 12/22/2018.This is a typo error on behalf of the ssu.The correct aware date was 12/22/2017.

Event Description

Ref#: (b)(4).

• Brand Name: QUART ARTERIAL FILTER WITH SOFTLINE COATING
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7174996
• MDR Text Key: 96852545
• Report Number: 8010762-2018-00011
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K090518
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: BO-HBF 140-J
• Device Catalogue Number: 701048784
• Device Lot Number: 70114693
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1