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 Occlusion Within Device (1423)

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

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

The product was disposed by the hospital; therefore a manufacturer laboratory investigation was not possible.A review for similar complaints with a product lab investigation performed was done and the following results could be obtained: the product was visual inspected in the lab of the manufacturer.Some clotted areas were visible on the outlet and inlet side.No clots were rinsed out during cleaning.The product was tested with bovine blood in the laboratory of the manufacturer for its o2, co2 transfer rate as well as for its pressure drop behavior at maximum flow.The product was operating according to the acceptance criteria's and therefore passed the test successfully.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.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: "there was a "shadow" on the cardiohelp oxygenator outlet side.The doctor looked at the shadow and decided to start heparin drip".The sales person told the customer that shadow did appear to be a clot forming and that if the customer had any fear that this would endanger the patient that the customer should change out the hls unit.The product was not exchanged.No patient consequences were reported" (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
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6471699
• MDR Text Key: 72416188
• Report Number: 8010762-2017-00116
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1