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

Model Number N/A

Device Problem Failure to Calibrate (2440)

Patient Problem Death (1802)

Event Date 11/24/2018

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that during use on a patient, the intra-aortic balloon pump (iabp) stopped pumping and generated a failure to calibrate alarm.The customer did not change the 40cc fiber optic cable balloon or the iabp.However, the user removed the fiber optic cable from the unit and allowed it to run off of the hemo pressure on semi-auto.The iabp therapy continued successfully and the patient was transferred to ccu.An hour later, the nurse noted that the iabp unit was alarming and notified the doctor.However, before the doctor could respond the patient coded and passed away.The date of the patient¿s death is unknown.The facility is not attributing the death to the device.The serial number or type of iabp involved in this event was not reported.The related iab report was submitted under mfg report# 2248146-2018-00741.

• Brand Name: UNKNOWN
• 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: 8191536
• MDR Text Key: 131221240
• Report Number: 2249723-2018-02206
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/21/2018
• 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): Death
• Patient Age: 81 YR
• Patient Weight: 67