MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR WITH INTEGRATED HEAT EXCHANGER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000 #SQUADROX-I ADULT + FILTER

Device Problems Coagulation in Device or Device Ingredient (1096); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The information provided to the manufacturer is as follows (no further information provided up to date): hmo71000: it became oxygenated from the middle.After replacing the circuit, the operation is finished.The product cannot be collected due to infectious disease patients.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Maquet gmbh requested the product in question for further investigation but the hls set was already disposed.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated was performed and no similar complaint was found.Thus the failure could not be confirmed.No root cause could be determined.The occurrence rate is below the acceptance rate, thus no remedial action 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.

• Brand Name: OXYGENATOR WITH INTEGRATED HEAT EXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9645916
• MDR Text Key: 195528320
• Report Number: 8010762-2020-00040
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: HMO 71000 #SQUADROX-I ADULT + FILTER
• Device Catalogue Number: 701067821
• Device Lot Number: 70131620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1