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 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump, s/n (b)(4), was in use on the patient from (b)(6) 2019 until (b)(6) 2020 (104 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 three layers, there are two more layers that will maintain the integrity of the air and blood chambers.The affected blood pump has not been returned to the manufacturer yet.A detailed investigation report will be provided as soon as it becomes available.

Event Description

Berlin heart was contacted by the (b)(6) distributor to report a suspected membrane defect in the excor blood pump of a patient supported in the lvad configuration.The distributor provided berlin heart with a picture of the blood pump at the time of the event.The affected blood pump was exchanged in the clinic by trained professionals without complications.The patient was not negatively affected by the incident and is doing well.

Manufacturer Narrative

During initial visual examination of the returned blood pump, red-brown deposits were seen between the membrane layers, confirming the customer complaint.The pump was then disassembled for further testing and the membrane layers were individually tested.A leakage was detected in the blood-side layer, located at the edge region of the membrane layer.The air-side layer and the middle layer were found to be intact.Dried blood deposits were detected between the blood-side layer and the middle layer of the triple layer membrane.The thickness of the blood-side layer and the adjacent layer were re-measured at defined points.The thickness of the middle layer was found to be within specification at all defined points.In the area around the leakage and in two of the defined points, the thickness profile of the blood-side layer was found not to be homogenous, at the time of the re-measurement.The cause of the leakage 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, 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 led to a leakage of the membrane at this location.

• 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: 9639442
• MDR Text Key: 199990653
• Report Number: 3004582654-2020-00010
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR