MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

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

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported from a customer from the us that after 3 days on support with hls set a clot formed pre-membrane and leading to a rise in delta p.The hls set was replaced.No indication of actual, or potential for harm, or death was reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "delta p increased due to clotting" occurred during use and the hls set was replaced.Investigation results: trend search.Dhr review.Ra review.The received product was investigated in mcp's laboratory on 2021-01-22 with the following outcome: a visual inspection was performed.No clotting detected.A tightness test according lv 201 und lv 202 was performed.No pressure drop could be detected.No leakage on the hls module noticed.Conclusion: no blood coagulation was found during the visual inspection and during the cleaning of the product.No leaks were found on the complaint sample during the leak test.In the subsequent function test of the centrifugal pump with liquid, all test speeds were successfully set and a flow of the test medium was thus established.When running dry, the pump only showed an imbalance at an increased speed of 3500 rpm.This can be traced back to the type of bearing (plain bearing) of the rotor and will not be pursued further, since the rotor showed no imbalance at the reference rotation of 150 rpm.This rules out any general inoperability of the product and the complaint could not be confirmed.It was not possible to determine a possible cause of a product related malfunction.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v26) following causes could lead to coagulation: de-airing luer lock connection too loose.Air remains in or enters the circuit.Hemostasis.Air or blood remains in luer lock access port.Too low anticoagulation.Too low at level, effect of heparin is too limited.Protamine sulfate enters the hls set.Administration of substitution of congealable substance such as plateles.Consumption) coagulopathy.Thrombozytopenia.Device history record (dhr) review was performed and there were no references found, which are indicating a nonconformance of the product in question.The reported failure "delta p increased due to clotting" occurred during use and could not be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse.

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10660884
• MDR Text Key: 211522928
• Report Number: 8010762-2020-00337
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• 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#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 01/26/2021
• Patient Sequence Number: 1