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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problems Entrapment of Device (1212); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Stroke/CVA (1770); Death (1802); Respiratory Distress (2045)
Event Date 01/30/2020
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2020 @1730 p. M. Est, teleflex received a call via the teleflex 24 hour customer hotline. It was reported by the rn from (b)(6) that a teleflex intra-aortic balloon (iab) had a ruptured balloon. The rn originally, called to discuss the condensation and drain failure alarms that were reported on (b)(6) 2020 @0752 est. The patient safety and reliability group internally asked the rn to call and ask if that was a common alarm. The clinical support specialist (css) discussed the alarm, when it occurs and how there is no bearing on the pump continuing to pump during the alarms. It was also discussed that once the rn did the manual purge as instructed by the css, the alarm did not reoccur. The rn asked about helium tank fluctuations as it went from 303psi prior to the purges the rn did to 281psi after. The css explained that with each purge, the tank vented to atmosphere and pulled helium from the tank so it is expected to see it go down with manual purges. The rn then asked about the bpw and the fact that this patient never had a sharp plateau and that it always had a slope to it. The css reviewed that could be kinking at the insertion site, anatomical tortuosity's etc. It then came up in conversation that this patient passed away after coding on the intra-aortic balloon pump (iabp) and the iab was taken out post arrest. The most accurate timeline of events that could be obtained from the rn. On (b)(6) 2020 evening pst the patient presented to ed with acute coronary syndrome (acs) and was taken to cath lab. Triple vessel disease was noted, the iabp inserted and therapy started, and the patient was admitted to the cardiac icu around 1030 pm pst. No vasoactive drips and scheduled for open heart surgery (ohs) on (b)(6) 2020. On (b)(6) 2020 @0752 a. M. Est the rn called the hotline and spoke to mike regarding drain failure alarms. Manual purge performed and no further alarms reported. On (b)(6) 2020 @1030 pst the rn noted an alarm on the pump which stopped the pump, the nurse checked the patient as she was at the head of the bed before checking the pump. Agonal breathing noted, respiratory code called. Another nurse came in and noted the possible helium loss alarm on the pump. The code ran for 30-45 minutes and no one had restarted the pump. The rn was unsure about how long the pump had not been pumping and told the cardiologist that they would not restart the pump since they could not verify how long it had been off. The css explained to the rn that the possible helium loss alarm stops the pump and someone would have had to restart for it to begin pumping again during the code. That had not been done the doctor agreed to pull the iab. Blood specks were noted in the helium driveline at some point post arrest. When the doctor attempted to remove the iab resistance was met. The patient was emergently taken to the operating room for a cut down. The iab was removed with some difficulty and thrombus was noted during cut down in the or at the site. Nursing notes show no decrease in pedal pulses leading up to the code (unchecked past the code). Another iab was not inserted at the decision of the physician. The patient was brought back to the unit. The iab was sent to internal pathology department for analysis. On (b)(6) 2020 ct scan showed ischemic and/or hemorrhagic (the rn could not find the final results during our conversation) event. Comfort care initiated and patient passed.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key9749819
MDR Text Key180718415
Report Number3010532612-2020-00049
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2020 Patient Sequence Number: 1
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