MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø12 MM; VENTRICULAR ASSIST DEVICE

Model Number P25P-001X01

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (71 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 blood pump is indicative of a blood-side layer defect.Investigation of the affected blood pump is currently ongoing and a detailed report will be submitted upon completion of the analysis.

Event Description

Berlin heart inc.Was contacted by the clinic on (b)(6) 2019 to report that blood has been detected around the pump housing in the excor blood pump of a patient supported in the lvad configuration.The clinic then provided berlin heart inc.Ca personnel with images of the affected blood pump.Upon evaluation of the images from the clinic, berlin heart inc.Clinical affairs recommended an immediate exchange of the blood pump due to a suspected membrane defect.The pump function did not appear to be affected during this event with 100% filling and emptying.Trained personnel at the clinic exchanged the blood pump on (b)(6) 2019 without incidence.The patient was not affected by this incident and is doing well.

Manufacturer Narrative

A part of the analysis was not included in the previous follow up.Below is additional information from the analysis.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.

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 deposits were 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 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.At the time of investigation, the thickness of the individual layers at all the fixed locations in the air-side and middle layer was found to be within specification.At the time of re-measurement, the thickness profile of the blood side layer was found not to be homogenous.

• Brand Name: EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø12 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 8575750
• MDR Text Key: 146209084
• Report Number: 3004582654-2019-00034
• 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,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 20