MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/19/2019

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.We have received no report of an alleged malfunction of the unspecified iabp and have requested additional information.If we receive any pertinent information, we will submit a supplemental report.Not returned to manufacturer.

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy; the iabp alarmed "check iab catheter", and that the intra-aortic balloon catheter (iabc) was replaced, but the patient did not survive.The faulty and defective catheter was put aside.Indications for use of iabp was coronary artery bypass grafting (cabg) procedure.The iabp model is unknown; however, there was no reported or alleged malfunction of the iabp.The facility does not attribute the patient's death to the iabp.Please refer to mfg report number 2248146-2019-00709 and 2248146-2019-00710 for reports on the involved iab catheters.

Manufacturer Narrative

An agent of the authorized getinge distributor has advised that the customer owns two cs100 units and that back in december 2018, their engineer inspected both iabps because they were out of order.After inspection, the engineer provided a repair quotation in december 2018 for repair of both units, but the facility opted to do the repairs on their own, then advised that the units were functional, but did not share any repair detail with the distributor.As far as the distributor is aware, no life items or 5000 hrs kit were replaced and the facility has continued to use the units.The distributor has no information on which of the cs100 units was involved in this complaint event.No further information is available.

Event Description

It was reported that during cs100 intra-aortic balloon pump (iabp) therapy; the iabp alarmed "check iab catheter", and that the intra-aortic balloon catheter (iabc) was replaced, but the patient did not survive.The faulty and defective catheter was put aside.Indications for use of iabp was coronary artery bypass grafting (cabg) procedure.There was no reported or alleged malfunction of the iabp.The facility does not attribute the patient's death to the iabp.Please refer to mfg report number 2248146-2019-00709 and 2248146-2019-00710 for reports on the involved iab catheters.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8926348
• MDR Text Key: 155419901
• Report Number: 2249723-2019-01354
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• 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: 0998-00-3013-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER; BALLOON CATHETER; BALLOON CATHETER
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 65