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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Off-Label Use (1494)

Patient Problems Perforation of Vessels (2135); Rupture (2208); Loss of consciousness (2418)

Event Date 01/21/2019

Event Type  Injury  

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.It was later reported that the facility's biomedical engineer (biomed) evaluated the iabp and replaced the power management board and pneumatic interface module due to blood contamination.In addition, the biomed indicated that fault code #53 which is related to a fiber optic sensor issue was also logged in the unit's diagnostic fault logs several times on the event date.Subsequently, a getinge service territory manager (stm) visited the event site and evaluated the iabp in connection with this reported blood back incident.No blood contaminated parts were observed; however, the stm performed preventative maintenance (pm) on the iabp.During the pm, the stm found that the compressor was unable to pass the calibration test due to 5000 hours expiration time reached.To resolve this issue, the stm replaced the compressor assembly and performed all calibration, safety and functionality checks per factory specifications.The iabp passed all tests per factory specifications and was returned to the customer and cleared for clinical service.Full name of initial reporter: (b)(6).

Event Description

The customer initially posed a question to a getinge representative requesting information on whether we have heard of any incidences where an intra-aortic balloon (iab) rupture was large enough to cause a stroke from an air embolism as the facility was investigating involvement of a "blood back" relative to patient condition and trying to understand "root cause".Getinge made further inquiries of the customer and the customer eventually reported that during cardiosave intra-aortic balloon pump (iabp) therapy, a patient was found to have lost consciousness, and that "iab catheter restriction" alarm continued as it had for the previous several hours.The iab was scheduled to be replaced later.After an acute event, the patient had a loss of consciousness, and it was determined that the patient needed to be intubated.At that time, blood was seen in the iab catheter tubing, and the catheter tubing was pulled to deflate the iab and clamped.The iab catheter was pulled soon after and a new iab catheter was not inserted.It is to be noted that the patient had a left axillary iab implanted which is an off-label use.No specific iabp malfunction was reported, and the customer has not attributed the patient harm to the iabp.The status of the patient is unknown.A separate report will be submitted for the involved iab catheter under (b)(4).

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 8363327
• MDR Text Key: 136985186
• Report Number: 2249723-2019-00296
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• 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
• Device Age: YR
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2012
• 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): Life Threatening
• Patient Age: 37 YR
• Patient Weight: 114