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

Model Number N/A

Device Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/31/2020

Event Type  Death  

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.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and observed a complete blood back.The stm noted that the entire pneumatic system needed to be replaced due to blood contamination and ordered all necessary parts.The stm returned to the customer's site at a later date and removed all contaminated parts and installed the drive manifold, safety disk, condensation removal module (crm), blood detect tubing, purge valve assembly, fill manifold bracket, single transducer block assembly, luer pneumatic component, reservoir assembly, hose, cable clamp, and the drive manifold insulator.Subsequently, the stm performed a complete pm including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during use, blood was observed in the tubing of the cs300 intra- aortic balloon pump (iabp).It was later reported that the patient expired.There was no reported malfunction of the iabp.Refer to mfg report number 2248146-2020-00486 for information on the intra-aortic balloon catheter (iabc).

Event Description

It was reported that during use, blood was observed in the tubing of the cs300 intra- aortic balloon pump (iabp).It was later reported that the patient expired.There was no reported malfunction of the iabp.Refer to mfg report number 2248146-2020-00486 for information on the intra-aortic balloon catheter (iabc).

• 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: 10580695
• MDR Text Key: 208350320
• Report Number: 2249723-2020-01552
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BALLOON.; UNKNOWN BALLOON.
• Patient Outcome(s): Death