MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,30 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P30P-001X01

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

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 (36 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 pump in question has been returned to the manufacturer and investigation is currently ongoing.A detailed report will be submitted as soon as available.

Event Description

We were informed by our italian distributor via the hotline that a black shadow appeared intermittently on the blood chamber of the excor blood pump of a patient supported in the lvad configuration.The clinic provided berlin heart with a video of the incident.Upon review, berlin heart (b)(4) clinical affairs personnel recommended an immediate 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

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 noted in the membrane interstice.For further investigation, the pump was submitted for an external ct examination.The individual membrane layers could not be distinguished from one another and the membrane interstice appeared to be filled with some medium.The blood-side layer appeared frayed at the position located directly opposite the entry canal in the de-airing port with a fragment protruding into the blood chamber.No other particles were detected.The pump was then disassembled for further testing and the membrane layers were individually tested.The blood-side layer displayed a punch-shaped leak opposite the de-airing port that had been noted in the ct-image as a frayed fragment.The defect corresponded in appearance to the shape and size of the de-airing cannula's tip.The other two membrane layers were found to be intact.A mixture of blood and dried blood particles were found between the blood-side and middle layer.No graphite agglomerates were noted between the layers.Based on the entry and exit points in the de-airing port, the direction of the entry canal for priming could be reconstructed and coincided with the damaged location in the blood-side layer.At the time of investigation, the thickness of the individual layers at all the fixed locations and also at the region of the defect was found to be within specification.The cause of the defect is most likely an accidental touch of the de-airing cannula on the membrane layers during pump preparation.This created an impression on the membrane layers, later resulting in a leak in the blood-side layer during pumping function.The defect led to a cushion between the middle and blood-side layer, filled with blood, which reduced the pump performance and was noted by the clinic personnel as a shadow on the blood chamber.

• Brand Name: EXCOR BLOOD PUMP PU VALVES,30 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: 8434667
• MDR Text Key: 142380940
• Report Number: 3004582654-2019-00023
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR