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 05/30/2019

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 (174 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 is indicative of an air-side membrane defect.A detailed investigation report will be provided as soon as available.

Event Description

Berlin heart was informed by the (b)(4) distributor of the replacement of an excor blood pump of a patient supported in the lvad configuration.The clinic noted an unusual membrane movement and a visible air cushion between the membrane layers.The clinic suspected a membrane defect and decided to perform an exchange of the affected blood pump.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

The customer complaint can be confirmed.During initial visual examination of the returned blood pump, an air cushion was detected between the membrane layers.The pump was then disassembled for further testing and the membrane layers were individually tested.A tear was noted in the air-side layer, located along the rolling radius of the stabilization ring.The middle and blood-side layers of the triple layer membrane were found to be intact.The thickness of the defective membrane layer and the adjacent layer of the returned blood pump was re-measured at fixed points.At the time of investigation, the thickness of these layers at all the fixed locations was found to be within specification.The measurement in the region of the leakages showed also that the thickness profile of the air-side layer was not homogeneous.During pumping operation it is possible for graphite particles to form due to abrasion between the membrane layers.This continuous abrasion for long time (174 days) can lead to a reduction in the thickness of the membrane at some points.In this case, abrasion reduced the thickness of the air-side membrane layer of this pump at one location.As a result, this layer was no longer homogeneous and underwent increased stress at this area of reduced thickness during pump operation.This finally resulted in a leakage of the air-side layer at that location.In this case, continued use may have led to an increase in the size of the leakage to a tear in the area of reduced membrane thickness.As a result of this defect, air got in and formed an air cushion in the membrane interstices, causing a reduced pump performance (incomplete filling and emptying).Our production records for the pump concerned confirm that at the time of production release, the thickness of the air-side layer was within specification and homogeneous across the fixed measuring locations.The abnormal membrane movement noted by the clinic was most probably a result of the membrane defect.

• 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: 8711874
• MDR Text Key: 148441839
• Report Number: 3004582654-2019-00059
• 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: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR