MAUDE Adverse Event Report: GETINGE GROUP / MAQUET CARDIOPULMONARY GMBH QUADROX-ID BIOLINE OXYGENATOR; FILTER BLOOD CARDIOPULMONARY BYPASS ARTERIAL LINE

Model Number 701067859

Device Problems Defective Device (2588); Material Integrity Problem (2978); Incomplete or Inadequate Priming (4041)

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

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Maquet medical systems usa ref# (b)(4), bioline quadrox oxygenators-no clamp, used in conjunction with the following devices to encompass a system.Issues noted following the change in mfr's specs that began in (b)(6) 2018.Please note that the following info is in ref to the newest design and have not seen this issue with the previous design.Using standard priming technique per mfr ifu, when the oxygenator is primed with plasmalyte, the oxygenator appears primed correctly, per our policy the device is then stored for no more than 30 days to be ready for use in an emergency if needed.During the 30-day window, it has been noted that the fluid level in the oxygenator is deprimed 1-2 inches below the deaeration port on the venous side.The deaeration port remains capped, with no ports open and no fluid puddles found.Oxygenator is off and prime lines closed.When primed with blood for use on a pt, we see venous side of the oxygenator suddenly become deprimed requiring add'l blood after priming is already complete.No other source air is noted on the venous side, nor in the priming line.The arterial side is noted to be priming from the bottom up with the top portion not primed.The top portion will only prime once fluid is pulled off the pigtail at the top of the oxygenator.Pre and post pressures are not affected and oxygenator appears to be functioning appropriately.Once in pt use, thrombus formation is noted in less than 24 hours after initial prime, at the top of the arterial side in the same area that was difficult to prime.After discussing the issue via phone with the getinge clinical specialist and account mgr, an email was prepared and sent on (b)(6) 2018 with our observation.On (b)(6) 2018, the vendor was contacted again and an add'l email sent with another instance of the event, this circuit was drained, saved, and made available to the mfr for investigation.This was picked up by the rep on (b)(6) 2018.During the visit by both getinge clinical specialist and the account rep, we were able to blood prime an add'l plasmalyte circuit, that was showing signs of issue (depriming while sitting) the blood prime was videotaped as part of the investigation by getinge.During the blood prime, the same issues, we are reporting occurred.The oxygenator was then drained and sent with the rep for investigation.Our concern at this time as the vendor has not been able to identify the defect that if this issue occurs without being caught prior to placement on a pt, it could cause severe injury or death to the pt.This issue is adding unexpected delay to pt care in time sensitive situations.All correspondence has been saved, video and photos of priming issues are available.

• Brand Name: QUADROX-ID BIOLINE OXYGENATOR
• Type of Device: FILTER BLOOD CARDIOPULMONARY BYPASS ARTERIAL LINE
• Manufacturer (Section D): GETINGE GROUP / MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 8180385
• MDR Text Key: 131374560
• Report Number: MW5082269
• Device Sequence Number: 0
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701067859
• Device Catalogue Number: BEQ-HMOD70000-USA
• Device Lot Number: (MULTIPLE)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1