MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BO HQV 112800

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

An oxygenator change had to be carried out due to acutely increased delta-p values during perfusion.The patient was not harmed.Complaint #: (b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

The squadrox-i + filtereinheit was directly involved in the incident which occurred during use.It was reported that delta-p values acutely increased during the perfusion.No harm or death was reported.The additional information was asked perfusion protocol via e-mail was received and attached to the parent record.No further information is available.The product was received back for investigation.Visual inspection was performed.Due to the contamination of the complaint sample, cleaning according to lv 205 was performed.Tightness test blood + water sides according to lv 201 and lv 202 were performed.No pressure build up due to clots could be observed when rinsing with water.A leak was found during the leak test on the blood side according to lv 201.A pressure drop of 0.6 bar is recorded after 6 hours.Thus, the complaint can be confirmed.Device history records for lot 92265136 and 70132566 were reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The information regarding anticoagulation management, ultrafiltration or hemoconcentration, regular measurements (activated clotting time, blood gas analysis, antithrombin 3, partial thromboplastin time) was asked however there was no further information.The information from customer was not sufficient to identify operational conditions.The reported failure was identified as part of current risk management file (dms #1464420 v15, chapters r1.3.1.1, r1.3.1.2, r2.4.3.2, r5.1.9.14, r5.1.21.1).Mitigations for this specific failures are in place per design specification and in instruction for use.Based on the information obtained so far within this investigation, the most probable root cause could be leakage in oxygenator blood side.The exact cause of the issue could not be identified.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10585084
• MDR Text Key: 208511611
• Report Number: 8010762-2020-00314
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: BO HQV 112800
• Device Catalogue Number: 70107.0947
• Device Lot Number: 92265136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 12/02/2020
• Patient Sequence Number: 1