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

Catalog Number 0998-00-0800-53

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 11/03/2017

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 getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and found that there was a piece of a connector from a fiber optic balloon that was broken off into the fiber optic sensor (fos) connector on the machine.The fse was able to fish the broken piece out.The internal fiber optic cable was unplugged from the back of the fos connector on the iabp unit.The fse speculated that this happened when someone tried to push another fiber optic balloon onto the connector, and this pushed the broken piece further back, which pushed the fos cable off of the connector.The fse then tested fiber optics and it passed.Shortly after, the fse turned the machine off and on, and tested it again; this time no transducer waveforms displayed.The fse also tried a new fos module, and it briefly worked, then stopped.The fos connections were acting intermittently and hard to pinpoint.The fse took apart the connector and pulled off the cable and all connections from the fos module, put it all back together and it would work.The fse was able to get the original fos module to work, with no errors.All connections were cleaned; the unit was tested for multiple hours and no further fos errors occurred.The fse performed full functional and safety tests; and the unit was returned to the customer for clinical use.

Event Description

It was reported that the fiber optic function of the intra-aortic balloon pump (iabp) was not working.The customer received fiber optic sensor (fos) errors.There was no patient involvement.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
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7063764
• MDR Text Key: 93686896
• Report Number: 2249723-2017-00875
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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