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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 Loose or Intermittent Connection (1371); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after switching from the first intra-aortic balloon pump (iabp), the rn reported helium loss alarms continuing. The clinical support specialist confirmed that there was no evidence of blood in the helium line tubing. As a result, the clinical support specialist had the registered nurse disconnect and reconnect the connections on the catheter to ensure it was tight. There was no further alarms after that. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device pump for investigation. The reported complaint of iabp helium loss is confirmed based on the investigation results of the iab used. A small external leak was identified on the mating connection between the short driveline and long driveline tubing. No alarms were noted during the iab complaint investigation; however, it is possible that a small external leak could cause or contribute to helium loss alarms. The root cause of the helium loss alarm is undetermined, but a potential cause is an external leak from the driveline connection. 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. A non-conformance has been initiated to further investigate the root cause.
 
Event Description
It was reported that after switching from the first intra-aortic balloon pump (iabp), the rn reported helium loss alarms continuing. The clinical support specialist confirmed that there was no evidence of blood in the helium line tubing. As a result, the clinical support specialist had the registered nurse disconnect and reconnect the connections on the catheter to ensure it was tight. There was no further alarms after that. There was no report of patient complications, serious injury or death.
 
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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 Key8663733
MDR Text Key146831514
Report Number3010532612-2019-00192
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 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2019
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 Received07/02/2019
Is This a Reprocessed and Reused Single-Use Device? No

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