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

Model Number P15P-001

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The excor blood pump,s/n (b)(4), was in use by the patient from (b)(6) 2018 to (b)(6) 2019 (78 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.The affected blood pump has not been returned to us yet.A detailed investigation report will be provided as soon as available.

Event Description

We were contacted by the clinic to report that a membrane defect was suspected in the right excor blood pump of a patient supported in the bvad configuration.An adjustment of the ikus parameters did not improve the pump performance.The clinic provided berlin heart with a video of the incident.Upon review, berlin heart clinical affairs personnel recommended an exchange of the affected blood pump.The blood pump was exchanged by trained professionals at the clinic.The exchange was performed without complications and the patient is doing well.

Manufacturer Narrative

Exemption number: e2013009.Berlin heart inc.(importer number: (b)(4)) is submitting the report on behalf of berlin heart gmbh(manufacturer).During initial visual examination of the returned blood pump, an air cushion was detected between the membrane layers.For further investigation, the pump was submitted for an external ct examination.An air cushion was detected between each of the membrane layers and a leak was detected in the middle layer.A small amount of particles could be seen between the membrane layers.The pump was then disassembled for further testing and the membrane layers were individually tested.Three leaks were detected in the middle layer and a leak was noted in the air-side layer.The leaks were located at the edge region.Furthermore, graphite agglomerates were detected between the membrane interstices.The blood-side layer was found to be intact.At the time of investigation, the thickness of the individual layers at all the fixed locations and also at the region of the leaks was found to be within specification.At the time of re-measurement, the thickness profile of the middle layer was found not to be homogenous.The cause of the defect 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 air-side and middle layers of the triple-layer membrane.As a result of this defect, air got in and formed an air cushion in the membrane interstices, causing the reduced pump performance (incomplete filling and emptying).

• 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: 8433124
• MDR Text Key: 142380167
• Report Number: 3004582654-2019-00020
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR