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 Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2019

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 (20 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 investigation of the affected blood pump is currently ongoing and a detailed report will be submitted upon completion of the analysis.

Event Description

Berlin heart was contacted by the (b)(4) distributor to report that dimples and a wrinkle were noted on the air-side layer of the triple layer membrane in the excor blood pump of a patient supported in the lvad configuration.Based on video material that the clinic provided, berlin heart recommended an exchange of the affected blood pump.The exchange was performed by trained professionals at the clinic on (b)(6) 2019.The exchange was performed without complications and the patient is doing well.

Manufacturer Narrative

The customer complaint is confirmed.The initial visual examination of the returned blood pump could not identify any dimples or a wrinkle on the membrane.The pump was then disassembled for further testing and the membrane layers were individually examined.All three membrane layers were found to be intact.Graphite agglomerates were detected between the membranes.These could be seen as dimples on the membrane surface.No membrane defect could be detected.The cause of the dimples noted on the membrane was most likely the graphite particles that formed due to an abrasion between the layers.The resulting graphite agglomerates led to a recurring optical abnormality.

• 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: 9168638
• MDR Text Key: 204402135
• Report Number: 3004582654-2019-00076
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 09/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR