MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P15P-001X01

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

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 (195 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.Initial visual inspection of the returned blood pump is indicative of a membrane defect.A detailed investigation report will be provided as soon as available.

Event Description

Pictures of an excor blood pump from a patient supported in the lvad configuration were send to berlin heart (b)(4).Berlin heart suspected a membrane defect and recommended an immediate exchange of the blood pump.The exchange of the excor blood pump was performed without complications.

Manufacturer Narrative

During initial visual examination of the returned blood pump, red-brown deposits were seen in the membrane interstices.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 along the edge region of the membrane layer.Several leakages were detected in the middle layer of the triple layer membrane, located near the center and at the edge region of the stabilization ring.The air-side layer was found to be intact.Dried blood were detected between the membrane layers.The thickness of the individual membrane layers of the returned blood pump was re-measured at fixed points.The thickness of the individual layers at all the fixed locations in the air-side and middle layer was found to be within specification.At the time of re-measurement, the thickness profile of the blood side layer in the area of the leakage was found not to be homogenous.The cause of the leak 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 leakage of the membrane at this location.The cause of the leaks in the middle layer was most likely the 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 of the triple-layer membrane.

• Brand Name: EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 9233393
• MDR Text Key: 206292256
• Report Number: 3004582654-2019-00079
• 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: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: P15P-001X01
• Device Catalogue Number: P15P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR