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

Model Number N/A

Device Problems Excess Flow or Over-Infusion (1311); Material Too Rigid or Stiff (1544); Ambient Temperature Problem (2878); Detachment of Device or Device Component (2907); Device Unsafe to Use in Environment (2918)

Patient Problem Death (1802)

Event Date 02/25/2019

Event Type  Death  

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 service territory manager (stm) was dispatched to the event site upon customer's request.The stm evaluated the iabp and found no issues with the unit.The stm completed full calibration, functionality, and safety checks on the system, and all tests passed to factory specifications.The iabp was then released for clinical use upon completion.(b)(6).

Event Description

It was reported that during transport of a patient outside to a fixed wing aircraft, the cardiosave intra-aortic balloon pump (iabp) lines were freezing up, causing disconnects and rapid helium use.It was also reported that the catheter extension became frozen during the patient transport in sub-zero weather (approximately -20 degrees f).The intra-aortic balloon catheter (iabc) would not stay attached and was very rigid.The therapy appeared to have failed due to the extreme cold.A patient death occurred; the date of the death is unknown.In addition, the customer requested that the iabp unit be inspected.At this time, it is unknown whether the customer is attributing the patient's death to the iabp.At this time it is unknown if the iabc was a getinge product.Additional information has been requested and a separate report will be submitted for it, if necessary.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8461910
• MDR Text Key: 140263714
• Report Number: 2249723-2019-00495
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• 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 Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 80