MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 # (b)(4).

Event Description

Complaint received via medwatch report # (b)(4) on 16-jun-2020.There was a leaking error when using maquet/datascope intra-aortic balloon pump that was cancelled last night and today.The patient was found to have air in the iliac arteries on ct.Iabp (intra-aortic balloon pump) was removed.Iabp was sequestered and biomed work order was put in for further evaluation/inspection.Date of event - (b)(6) 2019.

Event Description

Complaint received via medwatch report # (b)(4) on 16-june-2020.There was a leaking error when using maquet/datascope intra-aortic balloon pump that was cancelled last night and today.The patient was found to have air in the iliac arteries on ct.Iabp (intra-aortic balloon pump) was removed.Iabp was sequestered and biomed work order was put in for further evaluation/inspection.Date of event - (b)(6) 2019.

Manufacturer Narrative

Section d - device available for eval? from: yes, to: no.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.Reference complaint #: (b)(4).

• Brand Name: UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10233491
• MDR Text Key: 197931478
• Report Number: 2248146-2020-00329
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CH211974E5.
• Patient Outcome(s): Other