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

Model Number N/A

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 04/09/2019

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.A getinge field service engineer (fse) was dispatched to investigate.To determine which pumps were involved in incident, the fse went thru the fleet of eight pumps to examine the logs for anything that may indicate usage on the date and time in question: near midnight and after on (b)(6) 2019.The fse was able to locate one iabp unit that contained several logs pertaining to the time period for ¿leak in iab circuit¿ and ¿no pressure trigger¿.Thorough checkout and preventative maintenance was performed and no problems were found (reported under mfg report# 2249723-2019-00752).There were two other pumps that were in use at the time of the fse¿s visit and were not available to be evaluated.The fse returned to the customer's site at a later date and was unable to evaluate one of the two remaining pumps because it had been in use on a patient since the reported event.The fse reportedly completed a call on the last of the two iabps in question (for an unrelated issue) and all operations were good-no problem was found.The fse reported that if there were any logs from (b)(6) 2019, they were replaced by much newer logs since the maximum log events is 20.The fse was unable to state for sure which of these two pumps were involved in the incident because staff did not track the pumps involved.No further investigation is required.Device not returned to manufacturer.

Event Description

It was reported by supply chain personnel that a patient death occurred and the intra-aortic balloon (iab) had been retained by the facility.The supply chain personnel was advised by staff that a sensation plus iab catheter was inserted on (b)(6) 2019 (unknown clinical location).It was reported that upon start-up, the 1st cs300 intra-aortic balloon pump (iabp) involved would only pump a few beats and then would automatically go into standby mode.All connections were checked multiple times and still the iabp switched to standby mode with a low helium alarm.The staff tried changing out the pump twice ¿ both pumps also alarmed ¿low helium¿ but the staff did not relate the alarms that would have caused an interruption of pumping.This complaint is for the 3rd iabp used in this event.The staff did not know which pumps/serial numbers were involved.The getinge support representative requested that the personnel obtain further information and contact her in order to assist in getting the alarm history from the pumps.The getinge representative checked and found that there was no call for emergency clinical assistance from this account.The staff reported that she will attempt to obtain the information on the patient and the involved pumps for the fda report.The getinge company representative was later informed by the perfusion chief that the patient was not on the iabp when they expired.The patient had been taken off four (4) hours prior to the expiration.This death was due to factors not related to the balloon pump.After visual inspection of the catheter, the perfusion chief stated that it looked like there were several kinks in the catheter which would be expected as the patient was obese.All three pumps were put back into circulation of the facility¿s fleet, without noting the serial number of units involved.The customer stated that the problem was due to defective catheter and balloon.The facility is not attributing the patient's death to the iabp.This complaint is also related to iabp complaint mfg report# 2249723-2019-00754, 2249723-2019-00752 & iab mfg report# 2248146-2019-00394.

Event Description

It was reported by supply chain personnel that a patient death occurred and the intra-aortic balloon (iab) had been retained by the facility.The supply chain personnel was advised by staff that a sensation plus iab catheter was inserted on (b)(6) 2019 (unknown clinical location).It was reported that upon start-up, the 1st cs300 intra-aortic balloon pump (iabp) involved would only pump a few beats and then would automatically go into standby mode.All connections were checked multiple times and still the iabp switched to standby mode with a low helium alarm.The staff tried changing out the pump twice ¿ both pumps also alarmed ¿low helium¿ but the staff did not relate the alarms that would have caused an interruption of pumping.This complaint is for the 3rd iabp used in this event.The staff did not know which pumps/serial numbers were involved.The getinge support representative requested that the personnel obtain further information and contact her in order to assist in getting the alarm history from the pumps.The getinge representative checked and found that there was no call for emergency clinical assistance from this account.The staff reported that she will attempt to obtain the information on the patient and the involved pumps for the fda report.The getinge company representative was later informed by the perfusion chief that the patient was not on the iabp when they expired.The patient had been taken off four (4) hours prior to the expiration.This death was due to factors not related to the balloon pump.After visual inspection of the catheter, the perfusion chief stated that it looked like there were several kinks in the catheter which would be expected as the patient was obese.All three pumps were put back into circulation of the facility¿s fleet, without noting the serial number of units involved.The customer stated that the problem was due to defective catheter and balloon.The facility is not attributing the patient's death to the iabp.This complaint is also related to iabp complaint mfg report# (b)(4).The following report was received via medwatch# (b)(4): ¿alarming iabp (balloon pump).On arrival, iabp console show leak in system alarm.Checked all the connections multiple times.Whenever we click start on iabp, it works for less than a min then it automatically switch to standby mode.Checked connections multiple times, still the ibap switched to standby mode with the same alarm.Decision was made to remove iabp without removing the sheath in groin in case needed for emergency.Patient coded with refractory vt.Patient expired.Iabp kept stopping.Low helium alarms were occurring.Iabp was stopped and removed.Unclear if this was related to failure of iabp.Nursing staff went through changing 3 consoles.Iabp equipment not sequestered.Catheter available for review.¿.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8588602
• MDR Text Key: 144385516
• Report Number: 2249723-2019-00755
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS INTRA-AORTIC BALLOON (IAB) CATHETER.
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 119