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

Model Number BEQ-HLS 7050 USA#HL

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(6).Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was not 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 according to the customer "no visible clots.Not even in corners." based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.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

According to the customer: mentioned giving a anti clotting drug and had to change hls because of clotts.Clotting was suspected as pressure drop on the hls module was recognized during patient treatment.The set has been replaced during treatment.As stated by the customer no clots were visable in the replaced hls module.According to the customer: "the reason for changing the hls set was a pressure drop.He says no visible clots.Not even in corners.The drug was profilnine." no harm to the patient was reported.Internal reference: (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: 7565700
• MDR Text Key: 110463017
• Report Number: 8010762-2018-00200
• 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: 06/04/2018

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#HL
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1