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

Model Number N/A

Device Problems No Audible Alarm (1019); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was reviewed and no non-conformances related to the reported event were noted.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to the manufacturer.

Event Description

It was reported and stated by the customer that patient therapy was started with the cardiosave intra-aortic balloon pump (iabp) and sensation plus 50cc intra-aortic balloon (iab).Short time later the customer thought that the iab didn't sound right. with closer inspection and within 2 minutes of starting therapy, the customer noticed blood in the balloon tubing and decided to remove the balloon and replace it.The decision was made to withdraw the balloon through the sheath to keep the sheath operable. the customer stated that upon inspecting the iab after being removed, it was noticed that there were several small holes near the base of the iab.The customer questioned a getinge representative of why the iabp did not alarm and it was explained to them that without more details it would be impossible to guess. clinical representative was included on the call at this point as well. the customer asked if additional patient testing was warranted, and it was explained to the customer that this would be a clinical decision. the customer was not aware of any impact to the patient and did not mention or requested any follow-up. however, the customer also stated that they would like a follow-up after the iab has been inspected.No patient harm, serious injury or adverse event was reported.Please refer to manufacturer report number 2248146-2019-00583 for information on the involved iab.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8764844
• MDR Text Key: 150267628
• Report Number: 2249723-2019-01072
• 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: 07/03/2019

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 Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2019
• 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
• Patient Age: 73 YR
• Patient Weight: 74