MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device : a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported issue. The fse successfully completed a simulated treatment with trainer and testing catheter without issue. Also, identified various alarms for autofill failures and gas gain alarms, pointing to a potential leak. But the unit was fully functional otherwise, without any issues. The unit however, calibrated and passed all functional and safety tests per factory specifications. Returned to customer and cleared for clinical use. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) was giving multiple errors. The customer swapped out the unit to continue treatment. No patient harm, serious injury or adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14249926
• MDR Text Key: 290453090
• Report Number: 2249723-2022-00969
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1

Treatment

IAB CATHETER