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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
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.Complaint record id # (b)(4).
 
Event Description
It was reported after five days of intra-aortic balloon(iab) therapy, a pressure line tube was disconnected because it was confirmed that the 6-inch pressure monitoring tube was damaged.Pressure is input using an optical sensor, and treatment is continued because the inner lumen of this iab catheter was filled in heparinized saline solution, no leakage of blood was observed.The pressure tubing of the reported catheter was detached from its connector.A cap was put on the detached pressure tubing without replacing to another tubing.There was no reported injury to the patient.
 
Manufacturer Narrative
The pressure tubing was returned with blood on the interior.Upon further inspection, the pressure tubing port was found detached from the rest of the pressure tubing assembly.The evaluation confirmed the reported problem.However, we are unable to determine how or when this detachment may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record # (b)(4).
 
Event Description
It was reported after five days of intra-aortic balloon(iab) therapy, a pressure line tube was disconnected because it was confirmed that the 6-inch pressure monitoring tube was damaged.Pressure is input using an optical sensor, and treatment is continued because the inner lumen of this iab catheter was filled in heparinized saline solution, no leakage of blood was observed.The pressure tubing of the reported catheter was detached from its connector.A cap was put on the detached pressure tubing without replacing to another tubing.There was no reported injury to the patient.
 
Event Description
It was reported after five days of intra-aortic balloon(iab) therapy, a pressure line tube was disconnected because it was confirmed that the 6-inch pressure monitoring tube was damaged.Pressure is input using an optical sensor, and treatment is continued because the inner lumen of this iab catheter was filled in heparinized saline solution, no leakage of blood was observed.The pressure tubing of the reported catheter was detached from its connector.A cap was put on the detached pressure tubing without replacing to another tubing.There was no reported injury to the patient.
 
Manufacturer Narrative
A measurement of the tubing diameter was performed and was found to be within specifications.Under magnification, there was what appeared to be adhesive residue on both the tubing assembly and inside of the detached male port.The supplier quality department was informed, whom in turn contacted the supplier icu medical about the issue.Pictures of the tubing were provided to the supplier.Icu medical conducted an investigation and found that no non-conformances were associated to the tubing lot # 3948059, po (b)(4).The supplier confirmed that all inspections were done in compliance with their procedures and their in¿process steps.Additionally, the supplier confirmed that the seen glue residue in the provided photographs was evidence of adhesive on the tubing and indicated that the bond was performed correctly.There were no ncmrs or scars in the past for the reported issue, making this an isolated event.Based on the evaluation results, the failure is confirmed and the root cause is undeterminable.Based on the above product evaluation, since this is an isolated event, no further escalations were required.A 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).
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 35CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9619533
MDR Text Key187913877
Report Number2248146-2020-00040
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2022
Device Catalogue Number0684-00-0604
Device Lot Number3000095072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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