MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HMDO 30000#BE-QUADROX-ID PÄD.O.FILT.; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number QUADROX-ID PÄD.O.FI

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)

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

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Importer- (b)(4).

Event Description

According to the customer: clot formation has occurred inside the oxy.While formation of clots is common, it is uncommon for it to form on the inner clear plastic wall of the arterial side of the oxy.A surface clot is forming on the arterile side of the oxy.The position of the clot is on the inside of the clear plastic.Additional information: the incident occurred during patient treatment.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary(b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The oxygenator was investigated in the manufacturer laboratory on (b)(6)2018.A quadrox-id pediatric was sent back.Oxygenator was contaminated.A visual inspection was performed.There were no clots visible.No further abnormalities could be detected.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

Ref.: (b)(4).

• Brand Name: BE-HMDO 30000#BE-QUADROX-ID PÄD.O.FILT.
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7586893
• MDR Text Key: 111146183
• Report Number: 8010762-2018-00206
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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 Model Number: QUADROX-ID PÄD.O.FI
• Device Catalogue Number: 701047041
• Device Lot Number: 70119297
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1