MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENTOR, CARDIOPULMONARY BYPASS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA#Q

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was requested for return to the manufacturer for laboratory investigation but all four oxygenators are not any longer available.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.Thus the reported failure could not be confirmed the most probable root cause is unknown.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.According to information of the territory manager on (b)(6) 2018 each oxygenator was approximately 5 days in use.According to the ifu g-149 v04 chapter 2 "the maximum duration of use is 6 hours." the data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

According to the customer: oxygenator requiring change out for clotting every 5-6 days.The clotting was noticed on the inlet side.During one procedure five oxygenators were affected with the same problem.But only one of the five oxygenators is available for investigation.Oxy with the lot #70121445 will be return to the manufacturer.This oxygenator will handle in (b)(4).For the other four oxygenators a separate complaint was opened.This will be handled under (b)(4) in this report.The lot numbers of the four oxgenators are unknown and the oxygentors are not available for investigation.Incident required exchanges the oxygenators during use.No harm to the patient was reported.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).The product was requested for return to the manufacturer for laboratory investigation.After another request if the product is already shipped to germany for investigation.I received a statement of the principal perfusion territory manager: "customer opted to not return it.Customer states clotting occurred due to something they were doing".Therefore a investigation is not possible/necessary.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.According to information of the territory manager on (b)(6) 2018 each oxygenator was approximetely 5 days in use.According to the ifu g-149 v04 chapter 2 "the maximum duration of use is 6 hours." the data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Internal reference: (b)(4).

• Brand Name: OXYGENTOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7638106
• MDR Text Key: 112559955
• Report Number: 8010762-2018-00219
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD30000-USA#Q
• Device Catalogue Number: 701050330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention