MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 05/15/2018

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

Per medwatch report form (b)(4) received 20-august-2018: intra-aortic balloon pump (iabp) ruptured.Alarm on iabp kept going off.Nurse assessed the patient and the iabp, and during the assessment she noted blood in the helium tubing.Per procedure note at 13:21; "called to bedside per nurse, as there was concern iabp ruptured to remove.Patient was hemodynamically stable with blood pressure 92/56 and act 188 after heparin was discontinued.The iabp was placed on standby and balloon was pulled all the way out to the sheath and then they were both removed together.Blood was allowed to flow from the arterial puncture site for a few seconds to remove any thrombi.Manual pressure was applied for about 40 minutes with hemostasis obtained.Distal pulses where palpated after femstop placed.10 minutes after iabp was removed, patient remained stable with a normal blood pressure and heart rate at the same dose of levophed.Estimated blood loss: 10-20 cc.Complications: none.Conclusion: patient tolerated the procedure well.Continue icu monitoring for 24 hours with assessment of groin and distal pulses in right leg." this device in line for repair from getinge/maquet service tech, which can take up to two weeks.Getinge services tech tested, all tests are within normal operating parameters, device returned to service.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7860744
• MDR Text Key: 119935672
• Report Number: 2248146-2018-00539
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000048319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 62