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 Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump,s/n (b)(4), was in use by the patient from 2019-02-09 until 2019-06-18(129 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.The affected pump has not been returned yet.A detailed report will be submitted as soon as available.

Event Description

We were informed by the clinic about a suspected membrane defect of the blood-side layer of the triple-layer membrane of the left excor blood pump of a patient supported in the bivad configuration.Trained personnel at the clinic performed an exchange of the affected pump.The exchange was performed without complications and the patient was doing well again after the exchange.

Manufacturer Narrative

The customer complaint was confirmed.During initial visual examination of the returned blood pump, blood deposits were seen in the membrane interstices.The pump was then disassembled for further testing and the membrane layers were individually tested.A leak was detected in the blood-side layer at the edge region.The air-side and middle layers of the triple layer membrane were found to be intact.Dried blood deposits were detected between the middle and blood-side layer.The thickness of the defective layer, and the one adjacent was re-measured at fixed points.The thickness of the middle layer was found to be within specification at all locations.At the time of re-measurement, the thickness profile of the blood side layer was found not to be homogenous.The cause of the leak in the blood-side layer was an inhomogeneity in the membrane thickness of this layer.If the thickness distribution across a single membrane layer is not homogeneous, then there is the possibility that during pump function, the stresses in the material at the points of lower membrane thickness are higher than in the other areas of the membrane.In this case, this could lead to leakage of the membrane at these locations.

• 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: 8777350
• MDR Text Key: 150731076
• Report Number: 3004582654-2019-00062
• 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: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR