MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Pumping Stopped (1503)

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

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

The full name of the event site noted, is (b)(6).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company 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 the customer's site.The fse found that the problem was a clogged filter.The fse replaced the filter, calibrated the iabp and tested it on a service catheter for a ten hours.The fse is aware that the problem is connected to atmospheric pollution within the region of the hospital.The iabp was then released back into clinical use.The initial reporter named, is a getinge employee who has different contact details from that of the event site.Please refer to the following email as contact information for the initial reporter: (b)(6).

Event Description

It was reported that while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped pumping after an autofill, without emitting any alarm.The user was unable to start therapy again by pressing the start key, as the touchscreen was inactive.However, the display did not freeze and all was working well including the waveform display.The iabp was changed with another and therapy was continued.No patient harm or adverse event was reported.

Event Description

It was reported that while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) stopped pumping after an autofill, without emitting any alarm.The user was unable to start therapy again by pressing the start key, as the touchscreen was inactive.However, the display did not freeze and all was working well including the waveform display.The iabp was changed with another and therapy was continued.No patient harm or adverse event was reported.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to the customer's site.The fse found that the problem was a clogged filter.The fse replaced the filter, calibrated the iabp and tested it on a service catheter for a ten hours.The fse is aware that the problem is connected to atmospheric pollution within the region of the hospital.The iabp was then released back into clinical use.The full name of the event site noted in block e1 is (b)(6) for heart diseases.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F PLG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8056401
• MDR Text Key: 127873890
• Report Number: 2249723-2018-01951
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0