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 Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that blood drip from vent port of the hls module detected during <2 hours after initiating support.No leak noted during priming.Gas transfer not affected during pt support.Increasing rate of blood drip.Concern for clotting vent port.Circuit changed out.No harm to the patient was reported.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).The product was requested for return to the manufacturer for laboratory investigation.Sample was investigated in the laboratory on 2018-06-11: an hls module advanced 7.0 has been returned.The sample was contaminated.Sample cleaned with sodium hypochlorite.The visual inspection detected a damaged luer lock on the blood outlet side.It is not necessary to test the sample for leaks since the damage to the luer lock is visible.No abnormalities were noted on the screw cap.No further damage or other abnormalities were found.Conclusion: a leak can be confirmed.The visual inspection was a damaged luer lock of the blood outlet side.To test the pattern for tightness is not necessary since the damage on the luer lock is too big.On the screw cap were no abnormalities detected.No further damage or other abnormalities were found.Thus the failure could be confirmed.The most probable cause could be determined as excessive or inadequate external physical force that was exerted on the product after the release.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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
• 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: 7392496
• MDR Text Key: 104272282
• Report Number: 8010762-2018-00120
• 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,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2018
• 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