MAUDE Adverse Event Report: DATASCOPE CORPORATION Linear 7.5Fr. 40cc IAB with Accessories, US Only; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0480-01U

Device Problems Device Alarm System (1012); Backflow (1064)

Patient Problem Blood Loss (2597)

Event Date 04/06/2018

Event Type  malfunction  

Event Description

At approximately 1325, rn noted iabp alarming "check catheter." this rn noted only condensation in the helium tubing.Perfusion, site, and neurovascular checks are within normal limits.The iabp would not pump more than twice before alarming and putting the iabp into standby automatically.Helium tubing changed per iabp protocol at the first junction distal to the primary connection of the helium tubing at approximately 1330.Iabp still would not pump; still had check catheter alarm and was not providing a sustainable/appropriate augmented diastolic pressure until 1340.At this time the iabp would pump 1:1 on auto ecg without alarm and was providing an appropriate augmented diastolic.At approximately 1345, rn then noted there was fresh blood in the helium tubing proximal to the patient connection.Patient transported to cath lab at approximately 1420 for removal of iabp and arterial sheath and re-insertion of new axillary iabp/arterial sheath placement.Patient had stable vitals and neurovascular checks upon leaving cath lab.

• Brand Name: Linear 7.5Fr. 40cc IAB with Accessories, US Only
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORPORATION; 15 law dr; fairfield NJ 07004
• MDR Report Key: 8964608
• MDR Text Key: 156629312
• Report Number: 8964608
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019,05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0684-00-0480-01U
• Device Catalogue Number: 0684-00-0480-01U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Date Report to Manufacturer: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA