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 10/04/2019

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 (21 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 available pending return of the affected blood pump.

Event Description

Berlin heart was contacted by the (b)(4) distributor to report dimples on the membrane in the excor blood pump of a patient supported in the lvad configuration.The clinic provided videos and an image based on which 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 was doing well again.

Manufacturer Narrative

B2: outcomes attributed to adverse event: other serious (important medical events) was incorrectly clicked.There is no adverse event associated with this mdr.

Manufacturer Narrative

The initial visual examination of the returned blood pump could not identify any defects, no dimples were seen.Dimples can be seen when the membranes are under pressure, because then the distance between membranes layers is smallest.When the pump comes back for analysis, the membranes are not subjected to pressure and thus the distance between membrane layers is bigger and dimples are not likely to be seen on the surface of the air-side layer of the membrane.When pump was put under pressure, the dimples could be seen, confirming the customer complaint.For further analysis the pump was disassembled and the membrane layers were individually examined.Graphite agglomerates were found between the membranes.These could be seen as dimples on the membrane surface, confirming the clinic´s observation.All three membrane layers were intact.No membrane defect could be detected.The cause of the bumps (dimples) is most likely due the graphite particles formed by abrasion between the membranes.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: 9244051
• MDR Text Key: 203669000
• Report Number: 3004582654-2019-00082
• 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,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 10/04/2019
• Supplement Dates FDA Received: 10/29/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR