MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM; VENTRICULAR ASSIST DEVICE

Model Number P15P-001

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4) was in use by the patient from (b)(6) 2020 until (b)(6) 2020(161 days).We have reviewed the production records of the excor blood pump, s/n 1920588.This pump was produced according to our specification.The blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons.The entire membrane consists of an air-side layer, a middle layer and a blood-side layer.In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers.A detailed investigation report will be provided as soon as it is available.

Event Description

Berlin heart was contacted by the (b)(6) distributor to report a suspected membrane defect of the excor blood pump of a patient supported in lvad configuration.The affected blood pump was exchanged in the clinic by trained professionals without complications.The patient was not negatively affected by the incident and is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, no abnormalities were found.The blood pump was then tested for functional performance, where it did reach its required functional performance.The blood pump filled and emptied completely.Before further analysis, a ct scan was performed on the blood pump.All three layers of the three-layer membrane lie against one another, no air cushion was noted between layers.Particles can be seen between the membrane layers.A leak can be seen in the middle layer.The blood pump was disassembled for further testing and the membrane layers were individually examined.Two leakages were found in the middle layer of the triple layer membrane.The leakages in the middle layer are in the center of the membrane.Graphite agglomerates were found between the membranes.The air-side layer and the blood-side layer were found to be intact.The thickness of all three membrane layers was re-measured at the defined points.The thickness of the individual layers at all defined points was found to be within specification at the time of the re-measurement.The clinic also reported that the driving tube ran between the railings of the patients' bed.The surgeon removed and reconnected the driving tube from the ikus to take the patient to the operating room.After the driving tube was reconnected, the membrane gradually began to move again.It appears that driving tube may have been stuck (kinked) between the railings.This could be the reason why the video from the clinic showed that membrane of the blood pump does not move at all.Additionally, the clinic reported that when the membrane did not move, they got continuous "please check left pump and driving tube!" alarms from the driving unit, which would be generated in case of a defect in the diving unit or a kinked cannula.The cause of the leakages in the middle layer was most likely an abrasion between the membrane layers.This caused increased friction at some points, which finally led to the defect in the middle layer of the triple-layer membrane.The defect did not affect the functioning of the blood pump.

• Brand Name: BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 10706709
• MDR Text Key: 213039864
• Report Number: 3004582654-2020-00044
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: 04260090040157
• Combination Product (y/n): N
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR