MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P25P-001X01

Device Problem Output Problem (3005)

Patient Problems Low Cardiac Output (2501); No Code Available (3191)

Event Date 02/18/2019

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 until (b)(6) 2019 (111 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 is indicative of an air-side layer defect.A detailed investigation of the returned pump is currently ongoing and a report will be provided as soon as available.

Event Description

Berlin heart inc.Was contacted by the clinic to report reduced ejection in the excor blood pump supporting a patient with complex congenital heart disease with single ventricle physiology supported in the lvad configuration.The clinic provided berlin heart inc.With a video of the affected blood pump.Upon review of the video, an air cushion was suspected.At the same time, the patients clinical status declined and the patient required escalation in medical therapy, including intubation and the administration of pharmacological support, including inotropic support.Berlin heart inc clinical affairs personnel recommended an immediate exchange of the affected blood pump.The blood pump was exchanged by trained professional at the clinic.The exchange was performed without complications.The replacement blood pump functioned well with 100% filling and emptying.However, over the ensuing 24 hours, the patients clinical status continued to decline, requiring continued escalation of support and on (b)(6) 2019, the patient was transitioned from excor lvad support to ecmo, which was instituted via the existing excor vad cannulas.

Manufacturer Narrative

Exemption number: (b)(4).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.The blood pump was tested for functional performance.At the beginning, it did not meet the required pumping specification.For further investigation, the pump was submitted for an external ct scan.All three layers of the triple layer membrane lay parallel to one another and no air cushion was detected, air cushion may have been removed during functional testing.The pump was then disassembled for further testing and the membrane layers were individually inspected.A leak was detected in the air-side layer at the edge region.Graphite agglomerates were detected between the membrane layers.The other two layers were found to be intact.The thickness of the individual membrane layers of the returned blood pump was re-measured at fixed points.At the time of investigation, the thickness of the individual layers at all the fixed locations was found to be within specification.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 layer 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,25 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: 8433118
• MDR Text Key: 142380620
• Report Number: 3004582654-2019-00019
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: 04260090040119
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 1 YR
• Patient Weight: 6