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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 Device Alarm System (1012); Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the field service engineer was called in to service the pump, and during purge cycle, it was noted that the helium escaped out of the 1 psi relief valve due to fill valve #2 not opening.As a result, the cpm board was replaced.The pump ran for 18 hours without issue.The staff also noted that there was a system 7 error alarm.Although, the field service engineer could not reproduce the alarm.There was no report of patient consequence.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "helium leak" is not confirmed.Although, the root cause of the complaint is undetermined the cpm board passed functional test specifications during complaint investigation.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.This will be monitored for any developing trends.No further action required at this time.,,.
 
Event Description
It was reported that the field service engineer was called in to service the pump, and during purge cycle, it was noted that the helium escaped out of the 1 psi relief valve due to fill valve #2 not opening.As a result, the cpm board was replaced.The pump ran for 18 hours without issue.The staff also noted that there was a system 7 error alarm.Although, the field service engineer could not reproduce the alarm.There was no report of patient consequence.
 
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Brand Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8196867
MDR Text Key131479300
Report Number3010532612-2018-00420
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902084965
UDI-Public00801902084965
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 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Date Manufacturer Received01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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