MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Additional information relating to the event has been requested but not received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Patients delta p yesterday was 20mmhg but patient was having bleeding issues so provider turned off heparin overnight and early am noticed the delta p increasing to 40 with fibrins on the post-oxy side.Heparin was restarted again and now delta p is 80mmhg.Advised them to do a post-oxy abg assess oxy function and have change out supplies at the ready just in case they are needed.They did state that flows are staying at acceptable levels at this time and would just monitor and draw gases for now.(b)(4).

Manufacturer Narrative

The product was not available for investigation, therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints that were investigated had the following outcome: the product was visual inspected in the laboratory of the manufacturer.No clots were detected during rinsing of the product for cleaning purposes.The product was tested for its o2-transfer rate and co2 transfer rate as well as for its pressure drop at maximum flow.The gas exchange performance test and the pressure drop test meets the specification.Thus the reported failure could not be confirmed.The cause of this failure 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.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.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

(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7260072
• MDR Text Key: 99892965
• Report Number: 8010762-2018-00047
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• 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: 02/20/2018

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: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 02/20/2018
• Patient Sequence Number: 1