MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR VAD; VENTRICULAR (ASSISST) BYPASS

Model Number P15P-001

Device Problems Filling Problem (1233); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2020

Event Type  malfunction  

Event Description

We exchanged a berlin today - 1220 -[date redacted] because of clot.When we hooked up the new pump it was not emptying well nor was it filling well.We had given epi and the pressure was high so first i thought the systolic was just high and we could not pump.I turned the sys pressure up to 250 from 220 and no change.As we got the pressure down into the systolic of 80's from 130's there was still not good emptying.In fact it was maybe 30 % fill and 30% emptying.So i started to hand pump rapidly to get some hope of output.Dr [redacted] came back and we decided to change the pump.I went to prime a new pump, was back in a few minutes and we exchanged the pump again at 1245.The new pump was emptying and filling good even with high systolic's.Not sure what was the problem.

• Brand Name: EXCOR VAD
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; 9391 grogans mill road suite a6; the woodlands TX 77380
• MDR Report Key: 10733284
• MDR Text Key: 213001689
• Report Number: 10733284
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2020
• Device Age: 1 YR
• Date Report to Manufacturer: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 240 DA