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 12/12/2019

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

Event Description

We were contacted by our (b)(4) distributor to report a suspected membrane defect of the excor blood pump of a patient supported in the lvad configuration.The pump was exchanged by trained personnel at the clinic without complications and the patient is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, an air cushion could be detected between the membrane layers.For further investigation, the pump was submitted for an external ct examination.In between the air-side layer and the middle layer of the triple layer membrane, an air cushion was detected.For further analysis the pump was disassembled and the membrane layers were individually examined.A leakage was detected in the air-side layer along the rolling radius of the stabilization ring.Furthermore, graphite agglomerates were found between the membranes.The middle layer and the blood-side layer of the triple layer membrane were found to be intact.The thickness of the defect membrane layer and the adjacent layer of the returned blood pump was re-measured at defined points.The thickness of the individual layers at all defined points and in the area around the leakage was found to be within specification at the time of the re-measurement.The cause of the failure was most likely the graphite particles that formed due to abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer.As a result of this defect, air got in between the membrane layers and formed an air cushion, 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: 9571859
• MDR Text Key: 207175165
• Report Number: 3004582654-2020-00003
• 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: 01/12/2020

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: 04/30/2022
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR