MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems No Audible Alarm (1019); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) will be reviewed as soon as it is made available.Additional details have been requested.A supplemental report will be submitted when subsequent information is provided.

Event Description

During cs300 intra-aortic balloon pump (iabp) therapy, the end user reported that the intra-aortic balloon catheter (iabc) had a sluice lying down.During the therapy, blood/discoloration appeared in the helium tube.According to the user, the iabp did not deliver an alarm.The helium hose and the device were replaced.According to the user, the attending doctor requested an exchange for an iabc.This was the first iabp which was used to support the patient and there was no patient death associated with this unit.Please refer to mfg report number 2248146-2020-00155 for the related intra-aortic balloon catheter.

Manufacturer Narrative

A getinge field service engineer (fse) has advised that the iabp remains under lock and key in völklingen.However, the fse advised that during assessment, the iabp was opened and it was observed that the inner tube system came into contact with blood.The iabp is out of service and will no longer be repaired and used even when released.No further investigation is required.Updated fields: b4, g4, g7, h2, h3, h6 (evaluation method, result and conclusion codes), h10.

Event Description

During cs300 intra-aortic balloon pump (iabp) therapy, the end user reported that the intra-aortic balloon catheter (iabc) had a sluice lying down.During the therapy, blood/discoloration appeared in the helium tube.According to the user, the iabp did not deliver an alarm.The helium hose and the device were replaced.According to the user, the attending doctor requested an exchange for an iabc.This was the first iabp which was used to support the patient and there was no patient death associated with this unit.***it was later clarified that this 1st iabp was changed after it emitted an alarm and the diagnostic fault logs shows that this unit did alarm for a catheter related issue.Please refer to mfg report number 2248146-2020-00155 for the related intra-aortic balloon catheter.

Event Description

During cs300 intra-aortic balloon pump (iabp) therapy, the end user reported that the intra-aortic balloon catheter (iabc) had a sluice lying down.During the therapy, blood/discoloration appeared in the helium tube.According to the user, the iabp did not deliver an alarm.The helium hose and the device were replaced.According to the user, the attending doctor requested an exchange for an iabc.This was the first iabp which was used to support the patient and there was no patient death associated with this unit.It was later clarified that this 1st iabp was changed after it emitted an alarm and the diagnostic fault logs shows that this unit did alarm for a catheter related issue.Please refer to mfg report number 2248146-2020-00155 for the related intra-aortic balloon catheter.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.The customer has now requested getinge to service/repair the unit.We will submit a supplemental report when additional information is made available to us.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9866994
• MDR Text Key: 195369905
• Report Number: 2249723-2020-00468
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-61
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEGA 7.5FR. 40CC (SERIAL # (B)(6)); MEGA 7.5FR. 40CC (SERIAL # (B)(6)); MEGA 7.5FR. 40CC (SERIAL # (B)(6))
• Patient Age: 76 YR
• Patient Weight: 60