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

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided.The customer has not requested getinge to evaluate the iabp in question.However, additional information has been requested, and a supplemental report will be submitted.

Event Description

It was reported that during in use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a "catheter restriction" alarm.There were no indications of a leak present and the connections were secure when checked.Patient's flat suggested the possibility of a kink in the catheter.There was no unusual movement prior to the iabp alarming, and the patient was not on a ventilator.While a getinge representative was troubleshooting, the cardiologist walked in, and the nurse asked the representative to call back as he was assessing the situation.The representative then received an urgent call stating that the patient was coding; therefore, a call back was delayed about 45 mins.Upon calling back, the doctor reported trying to reposition the catheter which did not help.He stated that the patient's hemodynamics were good and was going to have the support discontinued.The patient was scheduled to go to the operating room and went for surgery about 30 minutes later.There was no report of patient injury or adverse event post-operatively.The related intra-aortic balloon (iab) to this event was reported under mfg report number 2248146-2018-00354.

Manufacturer Narrative

On (b)(4) 2018, we confirmed that there was an error with transposition of information involving this and another complaint (mfg report number 2249723-2018-00999), which resulted in the patient coding being incorrectly captured and reported under this complaint.However, there was no adverse event involved in this complaint and there was no alleged malfunction of the iabp.Complaint investigation is only required on the iab catheter; consequently, this complaint has been deemed invalid and will be cancelled in our database.

Event Description

It was reported that during in use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a "catheter restriction" alarm.There were no indications of a leak present and the connections were secure when checked.Patient's flat suggested the possibility of a kink in the catheter.There was no unusual movement prior to the iabp alarming, and the patient was not on a ventilator.No adverse event was reported.The related intra-aortic balloon (iab) to this event was reported under mfg report number 2248146-2018-00354.On (b)(6) 2018, we confirmed that there was an error with transposition of information involving this and another complaint (mfg report number 2249723-2018-00999), which resulted in the patient coding being incorrectly captured and reported under this complaint.However, there was no adverse event involved in this complaint and there was no alleged malfunction of the iabp.Complaint investigation is only required on the iab catheter; consequently, this complaint has been deemed invalid and will be cancelled in our database.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7545189
• MDR Text Key: 109306088
• Report Number: 2249723-2018-00892
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR
• Patient Weight: 78