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

Model Number P25P-001X02

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

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 (140 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 inspection of the returned pump is indicative a suspected membrane defect.Detailed investigation is currently ongoing.This particular model is not available in the usa, however a similar device is available, therefore, we are reporting under the mdr regulations.

Event Description

Berlin heart (b)(4) was informed by the (b)(6) distributor of a suspected membrane defect and reduced pumping function in the right excor blood pump of a patient supported in the bivad configuration.The affected blood pump was exchanged by trained personnel at the clinic.The replacement of the blood pump was without complications and the patient in doing well.

Manufacturer Narrative

Exemption number: e2013009.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,blood residue was seen in the membrane interstices.For further investigation, the pump was submitted for an external ct examination.Based on the ct images,deposits were seen between the membrane layers.The pump was then disassembled for further testing and the membrane layers were individually tested.A leak was detected in the blood-side layer and multiple leaks were detected in the middle layer.The leak in the blood-side layer was located at the center and the leaks in the middle layer between the edge region and the center of the membrane.The air-side layer of the triple layer membrane was found to be intact.Dried blood residues were detected between the membrane layers.At the time of investigation, the thickness of the individual layers at all the fixed locations and also at the defect locations in the blood-side layer was found to be within specification.At the time of re-measurement, the thickness profile of the middle layer and blood side layer was found not to be homogenous.The cause of the leaks in the middle and blood-side layer was an inhomogeneity in the membrane thickness of these layers.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: 8336928
• MDR Text Key: 139068200
• Report Number: 3004582654-2019-00013
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: P25P-001X02
• Device Catalogue Number: P25P-001X02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR