MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM; VENTRICULAR ASSIST DEVICE

Model Number P30P-001X01

Device Problem Output Problem (3005)

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

Event Date 08/24/2020

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(138 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).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

On(b)(6) 2020, the site contacted berlin heart inc.To report that a "black flash" was noted on blood side of the left excor blood pump in a patient supported in the bvad configuration.The patient was clinically stable at the time.The clinic provided berlin heart with a video of the blood pump at the time of the event.Berlin hearts clinical affairs team reviewed the video and recommended that the site exchange the blood pump.The affected blood pump was exchanged in the clinic by trained personnel.The exchange was performed without complications and the patient is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, an air cushion was detected between membrane layers.The blood pump was then tested for functional performance, where it did not reach its required functional performance.The visible black flash described by the clinic and as seen in the video sent by the clinic could not be reproduced under test conditions as no blood is used for functional testing during failure analysis.When a membrane is moving close to the pump housing, the gap between the membrane and the pump housing is so narrow, it can be seen as "black flash".The pump was then disassembled for further testing and the membrane layers were individually examined.In the air-side layer and the middle layer of the triple layer membrane a leakage was detected each.Both leakages were located along the rolling radius of the stabilization ring.The blood-side layer was found to be intact.Graphite agglomerates were detected between the membrane layers.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.In the area around the leakages, the thickness profile of the air-side layer and the middle layer was also found to be within specification at the time of the re-measurement.The cause of the leakages in the air-side layer and the middle layer was most likely graphite abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer and the middle layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion in the membrane interstices, causing the reduced pump performance.

• Brand Name: BLOOD PUMP PU VALVES 30 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: 10532480
• MDR Text Key: 207175114
• Report Number: 3004582654-2020-00033
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (y/n): N
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 20