MAUDE Adverse Event Report: BERLIN HEART GMBH 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 02/09/2020

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use by the patient from (b)(4) 2019 until (b)(4) 2020 (58 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 if it available.

Event Description

Berlin heart inc.Was contacted by the clinic to report a suspected membrane defect of the excor blood pump supported in the lvad configuration.The affected blood pump was exchanged in the clinic by trained professionals without complications.The patient was not negatively affected by the event and is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, an air cushion was detected between membrane layers.The pump was then disassembled for further testing and the membrane layers were individually examined.In the air-side layer and the middle layer of the triple layer membrane leakages were detected.The leakage in the air-side layer was located along the rolling radius of the stabilization ring.The leakages in the middle layer were distributed over the membrane surface.The blood-side layer was found to be intact.Graphite agglomerates were detected between the membrane layers.The thickness of all three membrane layers was re-measured at the defined points.The thickness of the individual layers at all defined points was found to be within specification at the time of the re-measurement.In the area around the leakages, which were not one of the defined points that were measured, the thickness profile of the air-side layer and the middle layer was also found to be within specification at the time of the re-measurement.The cause of the leakages in the air-side layer and the middle layer was most likely the graphite agglomerates 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 layer and the middle layer of the triple-layer membrane.As a result of this defect, air got in between the membrane layers and formed an air cushion in the membrane interstices, causing the reduced pump performance (incomplete filling and emptying).

• Brand Name: 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: 9720678
• MDR Text Key: 203979142
• Report Number: 3004582654-2020-00014
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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: 01/31/2020
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Weight: 4