MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR WITH INTEGRATED HEAT EXCHANGER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

They stated that approximately 0400 staff noticed a slight clot in the venous side of the oxygenator.The flow was between 5.5 and 6.0 liters per minute, with pre-membrane pressures less than 300mm hg.The staff decided to cut out and replace the oxygenator and did so without incident at approximately 0500.They reported no adverse patient effects.This complaint is related to # (b)(4).(b)(4).

Manufacturer Narrative

The getinge laboratory received the sample on 2019-06-21.The investigation has been performed by the laboratory on 2019-07-08.A tightness test according to lv 201 was performed and a leakage due to two cracks on the blood inlet side was detected.No pressure marks or other damage e.G.Due to force could be detected.Thus the failure could be confirmed.The most probable root cause for the clots was an exposure to air caused by the cracks.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Internal ref.#: (b)(4)/ onesupport: (b)(4).This complaint is related to # (b)(4).

• Brand Name: OXYGENATOR WITH INTEGRATED HEAT EXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8690923
• MDR Text Key: 147729488
• Report Number: 8010762-2019-00169
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 70106.7859
• Device Lot Number: 70125369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Date Manufacturer Received: 07/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention