MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-I ADULT OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 70000 U #SQUADROX-I ADULT OHNE FILT.

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

Rapid pressure increase with exploding delta p within a few minutes.The oxy was in use for exp.35 minutes.Complaint id: (b)(4).

Manufacturer Narrative

The device history record was reviewed on 2020-07-08.There were no references found, which are indicating a nonconformance of the product in question.Results of laboratory investigation (performed on 2020-10-15): during leak test a leakage at the de-airing membrane was noticed.As a most probable root cause it can be assumed that air entered the circuit due to the leakage leading to clotting and thus an increasing transmembrane pressure.Following possible root causes were determined for the leakage: -membrane untight; -bonding untight; -welding bar of the de-airing connection untight.Thus the failure could be confirmed.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-I ADULT OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10244714
• MDR Text Key: 199047802
• Report Number: 8010762-2020-00219
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2021
• Device Model Number: HMO 70000 U #SQUADROX-I ADULT OHNE FILT.
• Device Catalogue Number: 70106.7819
• Device Lot Number: 70133416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1