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

Model Number BE-HLS 7050

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

Patient Problems Death (1802); Vascular System (Circulation), Impaired (2572)

Event Date 03/09/2018

Event Type  Death  

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

According to the hospital: "lack of oxygenation (black artery) despite the entry of gas into the oxygenation compartment.The set worked 17 days without any anomaly.By lowering the flow under 1.5 l / min, increase in contact time and re-oxygenation of the artery.But beyond a flow > 2l / min the artery is no longer oxygenated.Change of the circuit in urgency.Clinical consequences: serious: deterioration of the patient's condition with non-optimal management.(b)(4).

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).(b)(6).A hls module advanced 7.0 was returned.The sample was contaminated and had to be cleaned several times with sodium hypochlorite.During the optical examination, a broken snap-in hook was detected on the blood inlet connector.Otherwise, no further defects were found.A further investigation (sawing open the oxygenator) is currently not possible for safety reasons.Corresponding measures have already been initiated.As soon as these measures have been implemented, the investigation can be resumed.A supplemental medwatch will be submitted if further information becomes available.

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: 7381256
• MDR Text Key: 103813389
• Report Number: 8010762-2018-00115
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701047753
• Device Lot Number: 70121578
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Date Device Manufactured: 12/01/2017
• 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
• Patient Outcome(s): Death