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 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge representative has advised that the safety disk assembly, condensation removal module (crm), and the tubing assembly have been replaced.Testing is ongoing and the iabp unit has not been returned to use.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a blood back event.It was noted that the iabp unit did not generate an alarm when blood was observed in the helium extension tube.Patient therapy was stopped, the intra-aortic balloon (iab) was replaced, and therapy was resumed without issue.There was no patient harm or injury and no adverse event was reported.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a blood back event.It was noted that the iabp unit did not generate an alarm when blood was observed in the helium extension tube.Patient therapy was stopped, the intra-aortic balloon (iab) was replaced, and therapy was resumed without issue.There was no patient harm or injury and no adverse event was reported.

Manufacturer Narrative

A getinge representative has advised that after replacing of the parts, all calibration, functional and safety checks to meet factory specifications were performed.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a blood back event.It was noted that the iabp unit did not generate an alarm when blood was observed in the helium extension tube.Patient therapy was stopped, the intra-aortic balloon (iab) was replaced, and therapy was resumed without issue.There was no patient harm or injury and no adverse event was reported.

• 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: 10517620
• MDR Text Key: 206779963
• Report Number: 2249723-2020-01474
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: 10607567108322
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 0998-00-3023-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSRAY PLUS 35CC