MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR / DATASCOPE CORP. INTRA-AORTIC BALLOON PUMP; SYSTEM BALLOON, INTRA-AORTIC AND CONTROL

Device Problems Inflation Problem (1310); Output Problem (3005)

Patient Problems Ventricular Tachycardia (2132); Loss of consciousness (2418)

Event Date 01/14/2019

Event Type  Injury  

Event Description

(b)(6): maquet femoral balloon pump was placed in the right leg on (b)(6) 2019 and was scheduled to have the axillary pump placed on monday (b)(6) 2019.On (b)(6) 2019 (sunday) approx 7:30 pm, the balloon pump started beeping.It took several people to make it start working again.Just after midnight, the pump started going off again.So many people tried to fix and/or figure out what was wrong.Dr (b)(6) happen to have been called in for another emergency and he came in.He did all he could think of and even called the rep (dr (b)(6) said that the rep thought there may be "micro-tears" in the balloon).I believe, from what i could gather, the pump wouldn't fill with helium.So, dr (b)(6) went back and forth with the decision to take out and replaced, or take it out and wait the 6 hrs or so until the axillary one was placed.Dr (b)(6) said he doesn't know what is going on with it, and that he had never had this happen before.At this point, the balloon pump was completely failed, and (b)(6) was in v-tach a lot.He was pretty much unconscious.Dr (b)(6) had been on the phone with dr (b)(6), who apparently told dr (b)(6) that (b)(6) wouldn't make it until morning if they took out and didn't replace it, so they needed to replace the pump.He was taken to the cath lab at about 3 am for a replacement maquet femoral balloon pump.I asked him what happened to the original pump.He indicated that he didn't see anything.He said that it was going to be sent back to the company for investigation and we would find out what happened.Tuesday (b)(6) 2019 and dr (b)(6) happened to walk by (b)(6) room.He stopped in, so i asked him what was happening with the faulty device.Dr (b)(6) said, he indicated that the he did not see any obvious defect when he took it out, but he called the company and they sent him a box to return the device in.He said he went back to the cath lab or wherever, the next day to retrieve the faulty device to send back and it was gone, someone had thrown it out.How does this happen? he also indicated that (b)(6) was not the only one this happened to.(didn't he say before that he had never seen this happen?).He assured us that they had the original lot numbers and that "maybe it was a bad batch of balloons," don't worry, we used a different lot number on the one he has in." it should also be known that while (b)(6) was in the icu waiting for a heart transplant, we became friendly with other's waiting.Between the 3 pts, there was a total of eleven failed balloon pumps from the same company.

• Brand Name: INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR / DATASCOPE CORP.
• MDR Report Key: 8444007
• MDR Text Key: 139802622
• Report Number: MW5085074
• Device Sequence Number: 0
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Life Threatening
• Patient Weight: 93