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

Device Problems Incorrect Measurement (1383); Infusion or Flow Problem (2964)

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

Event Date 08/19/2019

Event Type  malfunction  

Event Description

They stated that the facility is using hls 7.0 disposable with cardiohelp device.Customer stated they received "abnormally high internal pressures and therefore and abnormally high delta p".Customer states problem resolved by replacing the disposable.Further information was requested but we have not received an answer yet.(b)(4).

Event Description

Internal ref.# (b)(4), onesupport # (b)(4).

Manufacturer Narrative

It was stated that the customer did not notice any clots.Reported pressure values: pven -10, pint 415, part 122, deltap 293.Maquet cardiopulmonary gmbh requested the affected product for return on 2019-08-20.Sample received on 2020-01-15.The returned product was investigated in the laboratory of the manufacturer on 2020-03-16.The visual inspection of the hls oxygenator revealed no defects.During the leak test performed in accordance with lv 201 (blood side), a leak was detected on the pressure sensor located on the blood inlet cap.To make the sensor visible, the outer cover of the pump was removed.The sensor in the blood inlet cap has come loose from its hole (glue did not hold), which caused the leakage.The sensor was easily removed from the hole in the blood inlet cover using tweezers.Due to the loose pressure sensor in the blood inlet cap, the pressure measurement was incorrect.Thus the reported failure could be confirmed.The most probable root cause is that the sensor has loosened and therefore measured incorrectly.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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 trending.

• 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: 8959158
• MDR Text Key: 182553871
• Report Number: 8010762-2019-00276
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 03/16/2020
• Patient Sequence Number: 1