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 LINEAR 7.5 FR. 40CC; 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 LINEAR 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problem Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, icu charge nurse called to report frequent catheter restriction alarms on a cardiosave console.Troubleshooting could not resolve the problem.Tension on the catheter/reducing the augmentation setting/hyperextending the groin area.The balloon was not constantly immobile as it would pump 1-2 times between each alarm.She didn't know the circumstances but assured me that the patient wouldn't have flexed at the groin because he has a knee immobilizer on.An xray was obtained.The hospitalist called in the cardiology fellow to reposition or remove/replace the catheter.The balloon was removed.The customer also mentioned that he connected the balloon to the pump and it expanded as expected once removed.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: section e - event site email from: [blank] to: (b)(6).Reference complaint #(b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, icu charge nurse called to report frequent catheter restriction alarms on a cardiosave console.Troubleshooting could not resolve the problem.Tension on the catheter/reducing the augmentation setting/hyperextending the groin area.The balloon was not constantly immobile as it would pump 1-2 times between each alarm.She didn't know the circumstances but assured me that the patient wouldn't have flexed at the groin because he has a knee immobilizer on.An xray was obtained.The hospitalist called in the cardiology fellow to reposition or remove/replace the catheter.The balloon was removed.The customer also mentioned that he connected the balloon to the pump and it expanded as expected once removed.There was no reported injury to the patient.
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, icu charge nurse called to report frequent catheter restriction alarms on a cardiosave console.Troubleshooting could not resolve the problem.Tension on the catheter/reducing the augmentation setting/hyperextending the groin area.The balloon was not constantly immobile as it would pump 1-2 times between each alarm.She didn¿t know the circumstances but assured me that the patient wouldn¿t have flexed at the groin because he has a knee immobilizer on.An xray was obtained.The hospitalist called in the cardiology fellow to reposition or remove/replace the catheter.The balloon was removed.The customer also mentioned that he connected the balloon to the pump and it expanded as expected once removed.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: section d - lot # from: unknown.To: 3000106389.Section d - serial # from: unknown.To: (b)(6).Section d - exp.Date.From: [blank] to: 10/10/2022.Section h - manufacture date.From: [blank].To: 10/10/2019.The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter and the returned maquet sheath.A catheter tubing/inner lumen kink was observed near the y-fitting approximately 76.5cm from the iab tip.An underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.We are unable to duplicate the clinical setting.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
 
Event Description
It was reported during intra-aortic balloon(iab) therapy, icu charge nurse called to report frequent catheter restriction alarms on a cardiosave console.Troubleshooting could not resolve the problem.Tension on the catheter/reducing the augmentation setting/hyperextending the groin area.The balloon was not constantly immobile as it would pump 1-2 times between each alarm.She didn¿t know the circumstances but assured me that the patient wouldn¿t have flexed at the groin because he has a knee immobilizer on.An xray was obtained.The hospitalist called in the cardiology fellow to reposition or remove/replace the catheter.The balloon was removed.The customer also mentioned that he connected the balloon to the pump and it expanded as expected once removed.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information: return to manufacture date, device not eval provide code, evaluation method codes, evaluation result codes , evaluation conclusion codes, addtl mfg narrative/corr.Data 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINEAR 7.5 FR. 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9977825
MDR Text Key188272600
Report Number2248146-2020-00230
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/10/2022
Device Catalogue Number0684-00-0475
Device Lot Number3000106389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE; CARDIOSAVE; CARDIOSAVE; CARDIOSAVE; CARDIOSAVE
-
-