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

Model Number N/A

Device Problems Inability to Auto-Fill (1044); Break (1069); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to investigate.The fse performed full testing and calibrations and found that the iabp was working to specifications.The fse was unable to replicate the reported failure.The fse requested bts to do the electrical safety testing before handover.The iabp unit was cleared for clinical use.

Event Description

It was reported that a cardiosave intra-aortic balloon pump (iabp) was used on a patient with heart failure during transfer to (b)(6).A sensation plus 50cc intra-aortic balloon (iab) catheter was inserted in the right femoral artery (raf) and connected to fiber-optic with arterial line flush connected to a catheter.The patient was transferred to icu and the iabp was plugged into ac power.The patient was then transferred from (b)(6) hospital onto a (b)(6) plane/aircraft.The ccl nurse checked the placement of the catheter in the patient's groin before departing and the iabp was functioning normally.After approximately 30-40mins into the flight, the iabp unit was attempting to autofill and the unit went into standby mode.The nurse pressed the start button to re-commence pumping.The unit auto-filled and began pumping appropriately.The iabp went into standby mode again and had to be re-started.This occurred multiple times and the nurse noticed that the helium supply was draining quite quickly.The nurse checked the patient's groin, catheter tubing, connection of catheter into pump and all extension connections.There was no leak alarm or kink catheter alert throughout this period.There was no loose connections or blood/fluid observed in the catheter tubing.The nurse noted that the helium drained quickly, over a 20 minute period and then the unit went to standby mode.The catheter was disconnected from the iabp and manually inflated/deflated for the remainder of the trip to (b)(6).When the plane arrived at the airstrip, the patient was unable to be reconnected to the (b)(6) iabp unit, as the catheter was damaged from the syringe during the manual inflations.Following the event, the patient¿s condition was reported as stable and no adverse event 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: 7959982
• MDR Text Key: 123829449
• Report Number: 2249723-2018-01766
• Device Sequence Number: 0
• Product Code: DSP
• Reporter Country Code: AS
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-31
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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: 61 YR
• Patient Weight: 105