MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM; VENTRICULAR ASSIST DEVICE

Model Number P10P-001

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (172 days).We have reviewed the production records for 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 becomes available.

Event Description

We were contacted by the (b)(6) distributor to report a suspected membrane defect in the excor blood pump of a patient supported in the lvad configuration.The blood pump was exchanged by trained professionals at the clinic.The clinic provided a video and pictures of the blood pump at the time of the incident the exchange was performed without complications by trained personnel at the clinic.The patient was not affected by the incident and is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, red-brown deposits were seen between the membrane layers, confirming the customer complaint.The blood pump was then tested for functional performance where it did not meet its pumping specification.The pump was then disassembled for further testing and the membrane layers were individually tested.A leakage was detected in the blood-side layer, located at the edge region of the membrane layer.Additionally two leakages were detected in the middle layer, in the center of the membrane.The air-side layer was found to be intact.Dried blood deposits were detected between the membrane layers.The thickness of all three layers of the triple layer membrane were re-measured at defined points.The thickness of the individual layers at all defined points was found to be within specification.In the area around the leakage, which was not one of the defined points that was measured, the thickness profile of the blood-side layer was found not to be homogenous, at the time of the re-measurement.The cause of the leakage in the blood-side layer was an inhomogeneity in the membrane thickness of this layer.If the thickness distribution across a single membrane layer is not homogeneous, there is the possibility that during pump function, the stresses in the material at the points of lower membrane thickness are higher than in the other areas of the membrane.In this case, this led to a leakage of the membrane at this location.The cause of the leakages in the middle layer of the triple layer membrane was most likely graphite particles that formed due to an abrasion between the layers.This caused increased friction at points, which finally led to the defect in the middle layer.

• Brand Name: BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 9618148
• MDR Text Key: 204754240
• Report Number: 3004582654-2020-00008
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: 04260090040102
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: P10P-001
• Device Catalogue Number: P10P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR