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

Model Number N/A

Device Problems Backflow (1064); Fluid/Blood Leak (1250); Off-Label Use (1494)

Patient Problems Weakness (2145); Loss of consciousness (2418)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) will be reviewed once the dhr file is made available.A supplemental report will be submitted when additional information is made available.The name of the initial reporter listed is (b)(6).The full event site name is (b)(6).

Event Description

It was reported that a blood back occurred while the cs300 intra-aortic balloon pump (iabp) was in use on a patient.Frank blood was noted in the gas line.The patient became unresponsive and then woke up complaining of weakness on their side.An embolectomy was performed and the patient was able to move all extremities.The customer replaced the iab with another sensation plus 50cc; axillary approach (off-label use).It was reported that the embolectomy was not attributed to the iabp.There was no reported malfunction of the iabp unit.The related iab complaint has been reported under mfg report# 2248146-2018-00709.

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and replaced multiple parts that were contaminated with blood.The fse replaced single transducer block assembly, purge valve assembly, fill manifold assembly, luer connector, blood detect tubing, safety disk assembly and condensate removal module (crm).Full functional and safety checks were performed and passed to factory specifications.The iabp unit was returned to the customer for clinical service.

Event Description

It was reported that a blood back occurred while the cs300 intra-aortic balloon pump (iabp) was in use on a patient.Frank blood was noted in the gas line.The patient became unresponsive and then woke up complaining of weakness on their side.An embolectomy was performed and the patient was able to move all extremities.The customer replaced the iab with another sensation plus 50cc; axillary approach (off-label use).It was reported that the embolectomy was not attributed to the iabp.There was no reported malfunction of the iabp unit.The related iab complaint has been reported under mfg report# 2248146-2018-00709.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8171924
• MDR Text Key: 130614857
• Report Number: 2249723-2018-02164
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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
• Device Age: YR
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 29 YR