MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P15P-001

Device Problem Output Problem (3005)

Patient Problems Pulmonary Edema (2020); No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

The excor blood pump,s/n (b)(4),was in use by the patient from (b)(6) 2019 until (b)(6) 2019 (44 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 affected blood pump was returned to berlin heart for analysis following the exchange.The customer complaint could 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 leak was detected in the air-side layer, located along the rolling radius of the stabilization ring.Furthermore, a few graphite agglomerates were detected between the membrane interstices.The blood-side and middle layers of the triple layer membrane were found to be intact.The thickness of the defective membrane layer and the adjacent layer was re-measured at fixed points.At the time of investigation, the thickness of the layers at the fixed locations and also at the region of the defect was found to be within specification.The cause of the defect was most likely the graphite particles that formed due to an abrasion between the layers.This caused increased friction at points, which finally led to the defect in the air-side layer of the triple-layer membrane.As a result of this defect, air got in and formed an air cushion (pillow) in the membrane interstices, causing the reduced pump performance (incomplete filling and emptying).

Event Description

On (b)(6) 2019 around 2 am, incomplete ejection of the excor blood pump was noted and the patient condition was declining, febrile, hemodynamic instability and trouble breathing with decreased oxygen saturations that required intubation and mechanical ventilation.A chest x-ray was taken and pulmonary edema was noted.According to the site, an adjustment of the ikus did not improve the situation.Berlin heart was not notified until later that day after the event.The site sent berlin heart inc.A video.Upon review of the video, an air pillow was seen and berlin heart inc.Recommended an immediate exchange of the affected blood pump.Trained personnel at the site performed an exchange of the affected pump without complications and the patient was doing well again after the exchange.

• Brand Name: EXCOR 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
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 8827659
• MDR Text Key: 205122857
• Report Number: 3004582654-2019-00067
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: 04260090040157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 17 MO
• Patient Weight: 10