FDA.reportPublic FDA data

MAUDE MDR 6103696

MDR report key
6103696
Report number
3002879653-2016-00035
Event key
0
Event type
3
Date of event
2016-10-17
Date received
2016-11-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS IRIS RATKE
Address
BUSCHBERG 1 MELSUNGEN, 34212 GM
Phone
661-661-6617
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIALOG A + 1 BLOOD PUMP 120VHEMODIALYSIS SYSTEMB. BRAUN AVITUM AG - MELSUNGENFKJ710200K* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-1501. R

Event Narratives#

N

Patient 1

(B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY AND THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS ARE AVAILABLE.

D

Patient 1

AS REPORTED BY THE USER FACILITY: PATIENT RECEIVED HEMODIALYSIS POST PARACENTESIS PROCEDURE, WHICH REMOVED 4.6 LITERS OF FLUID. AFTER 9 MINUTES (61ML FLUID REMOVED) OF HEMODIALYSIS, PATIENT BECAME UNRESPONSIVE, RAPID RESPONSE TEAM WAS CALLED TO THE BEDSIDE, WHEREBY THE PATIENT BECAME RESPONSIVE UPON THE FIRST CHEST COMPRESSION. WAS MACHINE ALARM TRIGGERED: NO; PATIENT IS A CHRONIC DIALYSIS PATIENT; PER PHYSICIAN ORDERS, PATIENT DID NOT RESUME HEMODIALYSIS UNTIL THE FOLLOWING DAY; PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY AFTER HIS DIALYSIS WAS COMPLETED.

N

Patient 1

(B)(4). CUSTOMER REPORTED THAT IMMEDIATELY AFTER A PARACENTESIS WITH 4.6 L FLUID REMOVAL, A PATIENT RECEIVED HEMODIALYSIS WITH THE DIALOG" HEMODIALYSIS MACHINE (SN (B)(4)). ABOUT NINE MINUTES INTO TREATMENT, THE PATIENT BECAME UNRESPONSIVE. HEMODIALYSIS WAS DISCONTINUED. AFTER A FOLLOW UP CALL, THE CUSTOMER INDICATED THAT THE INTERVENTION MEASURES INCLUDED: DISCONTINUATION OF DIALYSIS; RETURNING THE PATIENTS BLOOD AND; INFUSING AN ADDITIONAL 1,000 ML OF SALINE PER PHYSICIAN ORDERS. PATIENT BECAME RESPONSIVE UPON FIRST CHEST COMPRESSION GIVEN BY THE HOSPITAL RAPID RESPONSE TEAM. PER PHYSICIAN ORDERS, PATIENT DID NOT RESUME HEMODIALYSIS UNTIL THE FOLLOWING DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY AFTER HIS DIALYSIS WAS COMPLETED. ALL INFORMATION AND MACHINE TREND FILES ASSOCIATED WITH THIS EVENT WERE FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN (B)(4). ACCORDING TO THEIR INVESTIGATION, THE EVALUATION OF THE TREND DATA RECORD OF THE DIALOG+ DIALYSIS MACHINE MATCHES THE DESCRIPTION OF THE CUSTOMER. AFTER 05:24 [MM:SS] OF THERAPY THE MACHINE WAS SWITCHED BY THE USER INTO BYPASS, THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS RETURNED AND THE THERAPY WAS TERMINATED. AT THIS TIME THE ULTRAFILTRATION VOLUME WAS 59 ML. THE TREND DATA OF THE THERAPY SHOWED THAT THE DIALOG+ MACHINE OPERATED AS INTENDED, WITHOUT ANY MALFUNCTION. ACCORDING TO THE MEDICAL ASSESSMENT PERFORMED BY THE MANUFACTURER, THE UNRESPONSIVENESS OF THE PATIENT IS ATTRIBUTABLE TO THE HIGH VOLUME DEPLETION DURING PARACENTESIS. IT CANNOT BE ATTRIBUTED TO ANY OTHER MEDICAL PROCEDURE OR TO THE MEDICAL DEVICE. ALL INFORMATION CONCERNING THIS INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, REVEALED NO ADVERSE TRENDS REGARDING THIS ISSUE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.