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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 Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the field service engineer (fse) that the cursor on the intra-aortic balloon pump (iabp) was stuck and would not move. Issue occurred during use on patient and the pump was swapped out. The fse could not reproduce the symptom. The iabp checked out okay. There was no report of patient harm or injury.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "the cursor being stuck" is not able to be confirmed. The field service agent serviced the pump and no issues was found. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported by the field service engineer (fse) that the cursor on the intra-aortic balloon pump (iabp) was stuck and would not move. Issue occurred during use on patient and the pump was swapped out. The fse could not reproduce the symptom. The iabp checked out okay. There was no report of patient harm or injury.
 
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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 Key7978263
MDR Text Key124128348
Report Number3010532612-2018-00315
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,health
Type of Report Initial,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
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 Received11/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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