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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problems Device Alarm System (1012); Failure to Reset (1532); Failure to Calibrate (2440)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). For related complaint see (b)(4).
 
Event Description
It was reported that at startup of the pump during an insertion of a fiber-optic intra-aortic balloon (iab), the pump gave an "fos out of range" alarm. They were unable to zero the fiber-optic prior to insertion. The alarm did not go away when the reset key was pressed. As a result, the patient was switched to a second pump. The fiber-optic was connected successfully and the pump is pumping without alarms. There was no report of delay of interruption of therapy. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "fos out of range alarm" was confirmed by the clinical support specialist; however, the biomed checked the pump and no problem found with the pump. 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. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The complaint will be monitored for any developing trends. No further action required at this time. Other remarks: for related complaint see (b)(4).
 
Event Description
It was reported that at startup of the pump during an insertion of a fiber-optic intra-aortic balloon (iab), the pump gave an "fos out of range" alarm. They were unable to zero the fiber-optic prior to insertion. The alarm did not go away when the reset key was pressed. As a result, the patient was switched to a second pump. The fiber-optic was connected successfully and the pump is pumping without alarms. There was no report of delay of interruption of therapy. There was no report of patient complication or serious injury and death.
 
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Brand NameAUTOCAT2 WAVE
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 Key7399106
MDR Text Key104734270
Report Number3010532612-2018-00064
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
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 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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