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 08/05/2019

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 (113 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.A detailed investigation report will be provided as soon as available.

Event Description

Berlin heart was contacted by the (b)(4) distributor to report an incomplete filling and emptying of the excor blood pump of a patient supported in the lvad configuration.Adjustment of the ikus stationary unit parameters did not improve the situation.An exchange was recommended by berlin heart cinical affairs (ca) personnel.The blood pump was exchanged by trained professionals at the clinic.The exchange was performed without complications and the patient 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 tested.A leak was detected each in the air-side layer and the middle layer of the triple-layer membrane.The leak in the air-side layer was located along the rolling radius of the stabilization ring.The leak in the middle layer was located close to the center.Graphite agglomerates were detected between the membrane layers.The blood-side layer of the triple layer membrane was 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 and the middle 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,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: 8944467
• MDR Text Key: 204402040
• Report Number: 3004582654-2019-00073
• 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: 08/29/2019

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: 08/12/2019
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR