• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BERLIN HEART GMBH EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
Type of DeviceVENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
BERLIN HEART GMBH
wiesenweg 10
berlin, 12247
GM 12247
MDR Report Key8827658
MDR Text Key152471080
Report Number3008454189-2019-00001
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040157
UDI-Public04260090040157
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
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 Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Model NumberP15P-001
Device Catalogue NumberP15P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2019
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer07/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/25/2019 Patient Sequence Number: 1
-
-