Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
  • 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
 

DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Filling Problem (1233); Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2019
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a autofill failure and gas gain alarm.The customer was able to resume pumping but only for a short while before the console would alarm again.They ended up switching pumps for another console and again received a gas gain alarm.They were able to resume pumping with the second console, but then the console stopped and showed system failure.The customer could not resume pumping.They powered down, and restarted the second pump, but again received the system failure alarm.At this time they went back to the first pump, but again received gas gain alarm and could not resume pumping.They were not in transport at the time, but when getinge representative called back they had just sent the patient via helicopter for transport to bryan medical center-east in lincoln nebraska for coronary bypass.The customer reports that they made the decision to leave the pump off and transport the patient.The catheter is still immobile in the patient.Physician recommended them not to do that and he felt the patient would be safe on the current heparin drip.The getinge representative advised per guidelines, it is recommended to manually inflate and deflate the balloon when it is in still for greater than 30 minutes.The iab was removed at the receiving facility prior to surgery.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a autofill failure and gas gain alarm.The customer was able to resume pumping but only for a short while before the console would alarm again.They ended up switching pumps for another console and again received a gas gain alarm.They were able to resume pumping with the second console, but then the console stopped and showed system failure.The customer could not resume pumping.They powered down, and restarted the second pump, but again received the system failure alarm.At this time they went back to the first pump, but again received gas gain alarm and could not resume pumping.They were not in transport at the time, but when getinge representative called back they had just sent the patient via helicopter for transport to bryan medical center-east in lincoln nebraska for coronary bypass.The customer reports that they made the decision to leave the pump off and transport the patient.The catheter is still immobile in the patient.Physician recommended them not to do that and he felt the patient would be safe on the current heparin drip.The getinge representative advised per guidelines, it is recommended to manually inflate and deflate the balloon when it is in still for greater than 30 minutes.The iab was removed at the receiving facility prior to surgery.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was non-maquet and was located over the catheter tubing.Four catheter kinks were observed approximately 48cm, 53.1cm, 61.5cm & 76.5cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.A device and lot history record review and trend evaluation was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint record # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8979465
MDR Text Key188824098
Report Number2248146-2019-00727
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000084491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight110
-
-