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

Model Number N/A

Device Problems Device Alarm System (1012); Inflation Problem (1310)

Patient Problem Loss of consciousness (2418)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.Additional information on this complaint event is being requested; a supplemental report will be submitted, if necessary.Full name of event site: (b)(6) university hospital.

Event Description

(b)(4) received a report from a patient who received cardiosave intra-aortic balloon pump (iabp) therapy as follows: "i am a recent iabp patient.On (b)(6) 2019 my pump failed and i was urgently rushed to the operating room.I am looking for information on how this pump could fail and put my life in danger.I was not contacted by any maquet rep or told what happened.I will be contacting the fda and perhaps the media and or attorney to make sure this gets the attention it deserves.It is my understanding that in 30 days 3 different patients had over ten failures.Please advise." medwatch# mw5085074 received on 01-apr-2019 with the following information: "maquet femoral balloon pump was placed in the right leg on 2019 and was scheduled to have the axillary pump placed on monday 2019.On 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 happened 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 said that the rep thought there may be "micro-tear" in the balloon).I believe, from what i could gather, the pump wouldn't fill them helium.So, dr 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 said he doesn't know what is going on with it, and that he has never has this happen before.At this point, the balloon pump was completely failed, and was in v-tach a lot.He was pretty much unconscious.Dr had been on the phone with dr, who apparently told dr that 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 2019 and dr happened to walk by room.He stopped in, so i asked him what was happening with the faulty device.Dr said, he indicated that he did not see any oblivious 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 has thrown it out.How does this happen? he also indicated that was not the only one this happened to (didn't he say before that he has never seen this happened?).He assured us that they has the original lot numbers and that "may be 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 patients, there was a total eleven failed balloon pumps from the same company." the iabp serial number is unknown at this time.Refer to related report on the intra-aortic balloon which was submitted under report #2248146-2019-00071.

• Brand Name: CARDIOSAVE
• 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: 8488961
• MDR Text Key: 141111305
• Report Number: 2249723-2019-00551
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 44 YR
• Patient Weight: 104