MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01U
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete event site name: (b)(6) medical.Occupation: administrator / supervisor - icu manager.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a check catheter alarm.It was also noted that blood was seen in the helium tubing.The iab was removed not replaced.The patient was stable without support.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text : device not returned.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12424771
• Report Number: 2248146-2021-00572
• Device Sequence Number: 4382113
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2023
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000133536
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 77