• 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 Tachycardia (2095); No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative
The excor blood pump, s/n (b)(4), was in use by the patient from 2018-10-29 until 2019-12-18(50 days). The patient was transplanted on (b)(6) 2020 and reported to be recovering well. Adverse event code: tachycardiac.
 
Event Description
Berlin heart inc was informed that while a blood pump that was not ejecting on a patient being supported in the lvad configuration, the patient had become tachypnic and was given o2 through a nasal cannula. Patient was given multiple fluid boluses of normal saline. Patient became more agitated and was given ativan. Inotropic support was also increased. Patient was then intubated and a chest x-ray was obtained. The patient arrested upon intubation and cpr was given. Patient received cpr for approximately 2 mins. Rosc following cpr. The complaint pump was then changed without further event to the patient.
 
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 Key9603908
MDR Text Key176611124
Report Number3008454189-2020-00001
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 Other Health Care Professional
Type of Report Initial
Report Date 01/17/2020,01/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2019
Device Model NumberP15P-001
Device Catalogue NumberP15P-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2020
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer12/18/2019
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: 01/17/2020 Patient Sequence Number: 1
-
-