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  Injury  

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
• MDR Report Key: 8827658
• MDR Text Key: 152471080
• Report Number: 3008454189-2019-00001
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: 04260090040157
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 17 MO
• Patient Weight: 10