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

Model Number 40CC

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 05/15/2018

Event Type  malfunction  

Event Description

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 femostop placed.10 minutes after iabp was removed, patient remained stable with a normal blood pressure and heart rate at 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 (b)(4)/maquet service tech, which can take up to two weeks.Getinge service tech tested, all tests are within normal operating parameters, device returned to service.

• Brand Name: INTRA AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law dr; fairfield NJ 07004
• MDR Report Key: 7776462
• MDR Text Key: 116880481
• Report Number: 7776462
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 40CC
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32850 DA