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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problems No Device Output (1435); Pumping Stopped (1503)
Patient Problems Arrhythmia (1721); Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 12/31/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) suddenly stopped without any alarm even when ecg readings were available. The pump stopped twice as a result, the pump had to be reset. There was a report of patient death. Dr. (b)(6) made the medical judgement that the patient's death was not caused or contributed by the device.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of iabp would not start pumping is not confirmed. A certified technician inspected the pump and no functional issues were noted. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) suddenly stopped without any alarm even when ecg readings were available. The pump stopped twice as a result, the pump had to be reset. There was a report of patient death. Dr. (b)(6) made the medical judgement that the patient's death was not caused or contributed by the device.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8270954
MDR Text Key133864769
Report Number3010532612-2019-00008
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No

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