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

Model Number N/A

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped working and generated a ¿system over temperature¿ alarm.The customer rebooted the unit; however, the problem did not resolve.The customer replaced the iabp and continued therapy.No adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse sent all the fault logs to the factory and awaited further feedback.The fse returned to the site and replaced the temperature sensor and the scroll compressor.The fse tested the iabp unit, performed the required calibrations and testing.The fse requested that the customer run the unit for more than 24 hours.Electrical safety testing was performed as per standard.The iabp unit was working within specifications and was released for clinical use.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped working and generated a ¿system over temperature¿ alarm.The customer rebooted the unit; however, the problem did not resolve.The customer replaced the iabp and continued therapy.No adverse event was reported.

Manufacturer Narrative

(follow-up 1: the iabp unit was working within specifications.However, it has not been confirmed whether te iabp was released for clinical use.) additional information was received stating that the customer was dissatisfied with the alarm event not registering in the error/fault logs.Because of this, the biomedical engineer has sequestered the iabp unit in the biomedical engineer department until an explanation is given regarding the log register for the temperature error.The getinge service representative informed the customer that over-temperature alarm message does not register in the fault logs.At the time of this report, it is unclear whether the iabp has been released to clinical use.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped working and generated a ¿system over temperature¿ alarm.The customer rebooted the unit; however, the problem did not resolve.The customer replaced the iabp and continued therapy.No adverse event was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7919433
• MDR Text Key: 122194321
• Report Number: 2249723-2018-01679
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• 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?: Yes
• Device Age: YR
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 80