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

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem Death (1802)

Event Date 05/03/2018

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. There was no alleged malfunction of the iabp; however, a supplemental report will be submitted if additional information is provided.

Event Description

Customer called getinge for assistance with a patient on a cs300 intra aortic balloon pump (iabp) with a getinge fiber optic intra-aortic balloon (iab) in place. There was a full code situation going on with loss of optical sensor and ecg signal and the iabp displayed "optical sensor failure" during cardiopulmonary resuscitation (cpr) and it was believed that there was a possible break of the fiber optic catheter due to cpr. The clinicians attempted to establish blood pressure signal via central lumen but they were having trouble finding the cable. The patient was revived but with poor ecg activity still present. The getinge representative instructed the nurse to switch to semi-auto and attempt to find a lead that could be seen. Weak signal was established in avr (augmented vector right) but not strong enough for the iabp to pick-up r waves. Customer finally found the cable and hooked up the transducer, but the patient was coding again. After zeroing, they were able to get a pressure signal from cpr effort and the iabp began assisting during code. The getinge representative called back after one hour and was advised that a patient code was called. The getting representative discussed some issues with the customer such as making sure they had cables on each iabp for pressure transducer. The patient died from an unknown underlying disease, and the patient death is not attributed to the iabp. The date of the death is unknown. Refer to mfg report number 2248146-2018-00364 for balloon catheter information. Please note that there was an error with transposition of information involving this and another complaint (mfg report number 2249723-2018-00892), which resulted in the patient coding being incorrectly captured and reported under the afore-referenced report number.

• Brand Name: CS300
• 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: 7597098
• MDR Text Key: 110935034
• Report Number: 2249723-2018-00999
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/13/2018 Patient Sequence Number: 1

Treatment

SENSATION UNKNOWN IAB