• 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  malfunction  
Manufacturer Narrative
The excor blood pump, s/n (b)(4), was in use by the patient from (b)(6) 2018 until (b)(6) 2019 (50 days). The patient was transplanted on (b)(6) 2020 and reported to be recovering well. We have reviewed the production records of the excor blood pump, s/n (b)(4). This pump was produced according to our specification. The blood pump is designed with a triple layer membrane separating the air chamber from blood chamber for safety reasons. The entire membrane consists of an air-side layer, a middle layer and a blood-side layer. In case of disruption in one of the triple layers, there are two more layers that will maintain the integrity of the air and blood chambers. Initial visual inspection of the returned blood pump is indicative of a membrane defect. The investigation of the affected blood pump is currently ongoing and a detailed report will be submitted upon completion of the analysis.
 
Event Description
Berlin heart inc was informed about a pump that was not ejecting on a patient being supported in the lvad configuration. At the time of the incident, the patient became 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
Manufacturer (Section G)
BERLIN HEART GMBH
wiesenweg 10
berlin, 12247
GM 12247
Manufacturer Contact
dudley rajapaksa
9391 grogans mill road
suite a-6
the woodlands, TX 77380
2818639706
MDR Report Key9603846
MDR Text Key196062211
Report Number3004582654-2020-00006
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier04260090040157
UDI-Public04260090040157
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 01/17/2020
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? Yes
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?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/17/2020 Patient Sequence Number: 1
-
-