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

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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product was not requested for return for further investigation in the laboratory of the manufacturer as the failure is already known to mcp a capa process (capa (b)(4)) was initiated.All further action in regard to the reported failure will be performed out of capa (b)(4).Thus the failure could be confirmed.In order to determine the root cause it will be performed out of the capa (b)(4) process.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

It was reported from a customer from the us that blood leakage at dialysis lock with valve was noticed during veno-arterial cp support on the hmod 70000.Dr.(b)(6) cardiac surgeon initiated support at 1135hrs on (b)(6) 2019.Leak was noticed at 1400 hrs (b)(6) 2019.Dr.(b)(6) changed the circuit with (b)(6) ccp.The unit was exchanged.Circuit "off" for 1 minute during exchange.700 ml blood loss due to the circuit change.No harm to the patient was reported.Complaint id: (b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 8938830
• MDR Text Key: 182551752
• Report Number: 8010762-2019-00266
• 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,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 70128240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1