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

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

They stated that the anticoagulation was good and the hls oxygenator clotted off quickly after the patient was on support for 48 hours.Further information 2019-06-14: patient went on support (b)(6) 2019 at 1830 and circuit clotted and changed on (b)(6) 2019 at 0815.Pt was on a heparin drip.Delta p was 137.No harm to the patient was recorded except the time off of support during the change.Further information were requested but not yet received.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product for investigation but the product was already discarded.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.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : they already scrapped the device.

Event Description

Internal ref.#: (b)(4)./ onesupport: (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8726583
• MDR Text Key: 149102577
• Report Number: 8010762-2019-00186
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 70128330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention