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

Catalog Number 0998-00-0800-53

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to evaluate the iabp and reported that per the iabp's diagnostic fault log, the last fill fail alarm occurred on (b)(6)2017.The fse observed that "auto-fill error 37" had three (3) occurrences, two (2) of which occurred on (b)(6)2016.The fault log also listed "gas loss in iab circuit" on both (b)(6)2017.The fse ran checks and placed the iabp on a test balloon and the iabp passed all functional and safety tests per factory specifications.The fse then returned the iabp to the customer and cleared it for clinical use.

Event Description

The customer reported that the intra-aortic balloon pump (iabp) had fill frequency issues and as a result, customer pulled the iabp from service.The circumstances of the event are unknown; however, no patient involvement has been reported, and 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: 6691317
• MDR Text Key: 79399253
• Report Number: 2249723-2017-00059
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/06/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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