MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Defective Alarm (1014); Inability to Auto-Fill (1044); Self-Activation or Keying (1557); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

It was reported that an intra-aortic balloon (iab) was inserted in radiofrequency ablation (rfa) and connected to fiber-optic with arterial line flush connected to catheter for a patient with heart failure and transfer to the customer site.The iab was inserted under fluroscopy in the cardio cath lab (ccl) and position was checked.Both sheath and catheter were secured with sutures.Therapy was commenced at 1811hrs, timing 1:2, augementation 100%.Patient was transferred to intensive care unit at 1908hrs and balloon pump was plugged into ac power.Patient was transferred from facility onto a royal flying doctors service (rfds) plane at2105hrs, departing at 2212hrs.Ccl nurse checked the patients groin and catheter before departing and pump was functioning normally.At the beginning of the flight the iab pump (iabp) was functioning normally.After approx 30/40mins the iabp was attempting to autofill went into standby mode.The nurse had to press the start button to re-commence pumping.The iabp autofilled and began pumping appropriately.Then the pump went back into standby mode, where it had to be re-started again.This occurred multiple times and the nurse noticed that helium supply was draining quite quickly.The nurse checked the patient's groin, catheter tubing, connection of catheter into pump and all extension connections.There was never a leak alarm or kink catheter alert throughout this period.Everything was secure, there was no loose connections or blood/fluid observed in the catheter tubing.The helium drained quickly over a 20min period and then pump went to standby mode at 2308hrs.The catheter was disconnected from the iabp and manually inflated/deflated for the remainder of the trip to the customer site.After helium had run out, the nurse had to disconnect the catheter from the pump and manually inflate/deflate the balloon for the remaining duration of flight.There was no 3-way stopcock in nurse's transport bag and therefore the nurse had to place the syringe directly onto the catheter tubing.This did cause damage to the connection port of the iab catheter and therefore the catheter was unable to be transferred to a different unit to continue pumping from the airstrip to the customer site.The plane arrived at the airstrip at 0110hrs.The patient was unable to be reconnected at the customer site as the catheter was damaged from the syringe during the manual inflations.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The pressure tubing and a non-maquet syringe was also returned.No damage was observed on the returned iab catheter.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).

Event Description

It was reported that an intra-aortic balloon (iab) was inserted in radio frequency ablation (rfa) and connected to fiber-optic with arterial line flush connected to catheter for a patient with heart failure and transfer to the customer site.The iab was inserted under fluoroscopy in the cardio cath lab (ccl) and position was checked.Both sheath and catheter were secured with sutures.Therapy was commenced at 1811hrs, timing 1:2, augmentation 100%.Patient was transferred to intensive care unit at 1908hrs and balloon pump was plugged into ac power.Patient was transferred from facility onto a royal flying doctors service (rfds) plane at 2105hrs, departing at 2212hrs.Ccl nurse checked the patients groin and catheter before departing and pump was functioning normally.At the beginning of the flight the iab pump (iabp) was functioning normally.After approx 30/40mins the iabp was attempting to autofill went into standby mode.The nurse had to press the start button to re-commence pumping.The iabp autofilled and began pumping appropriately.Then the pump went back into standby mode, where it had to be re-started again.This occurred multiple times and the nurse noticed that helium supply was draining quite quickly.The nurse checked the patient's groin, catheter tubing, connection of catheter into pump and all extension connections.There was never a leak alarm or kink catheter alert throughout this period.Everything was secure, there was no loose connections or blood/fluid observed in the catheter tubing.The helium drained quickly over a 20min period and then pump went to standby mode at 2308hrs.The catheter was disconnected from the iabp and manually inflated/deflated for the remainder of the trip to the customer site.After helium had run out, the nurse had to disconnect the catheter from the pump and manually inflate/deflate the balloon for the remaining duration of flight.There was no 3-way stopcock in nurse's transport bag and therefore the nurse had to place the syringe directly onto the catheter tubing.This did cause damage to the connection port of the iab catheter and therefore the catheter was unable to be transferred to a different unit to continue pumping from the airstrip to the customer site.The plane arrived at the airstrip at 0110hrs.The patient was unable to be reconnected at the customer site as the catheter was damaged from the syringe during the manual inflations.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7944544
• MDR Text Key: 123814347
• Report Number: 2248146-2018-00575
• Device Sequence Number: 0
• Product Code: DSP
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000069503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Device Age: YR
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Age: 61 YR
• Patient Weight: 105