MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PAD.O.FILT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient require 2 oxy changes just over 24 hours due to climbing pressures.Complaint #(b)(4).

Manufacturer Narrative

The quadrox-id was directly involved in the incident which occurred during patient treatment.It was reported that a patient require 2 oxy changes just over 24 hours due to climbing pressures.Maquet cardiopulmonary gmbh requested the affected product for return on 2020-10-28.Sample received on 2020-11-13.The returned product was investigated in the laboratory of the manufacturer on 2020-12-14.Cleaning according to lv 205 did not reveal any abnormalities with regard to leakage.Clots were observed which were flushed out of the tubes of oxygenator 1.Clots in the oxygenator 1 can be a cause of climbing pressures.Thus the reported failure could be confirmed.For the oxygenator 2, no accessory tubing was included and no clots could be detected during flushing.The leak test of the water side according to lv 202 did not show any pressure drop.According to the risk assessment (quadrox-id, pediatric, dms#1462367) there are following causes which can lead to the reported failure: -high centrifugal pump speed in combination with restriction of blood flow, high pressure and shunts leading to excessive shear forces; -mechanical red cell degradation; -wrong administration of protamine.Device history record (dhr) review result for the oxy 1 with the lot# 70140824.Affected product: basic lot 70137549 and packaging lot 70140824 (serial number (b)(6)).The avz from 1585548 to 1585563 (dms#2179320) has been reviewed for the reported failure on (b)(6) 2020.There were no references found, which are indicating a nonconformance of the product in question.Device history record (dhr) review result for the oxy 2 with the lot# 70137553.Affected product: basic lot 70137549 and packaging lot 70137553 (serial number (b)(6)).The avz from 1585532 to 1585547 (dms#2179320) has been reviewed for the reported failure on (b)(6) 2020.There were no references found, which are indicating a nonconformance of the product in question.The occurrence rate was calculated for the reported issue 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 #(b)(4).

• Brand Name: QUADROX-ID PAD.O.FILT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10749490
• MDR Text Key: 213503105
• Report Number: 8010762-2020-00357
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
• Device Catalogue Number: 70105.0330
• Device Lot Number: 70137553
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1