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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); Low Battery (2584); Battery Problem (2885)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "pump shut off on battery power" is not able to be confirmed. The pump was checked by the hospital biomed, could not replicate the battery problem. 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 rn that when transporting a patient from the cath lab to the intensive care unit they unplugged the pump from power and the pump alarmed as it should that it was on battery. It again alarmed within a few seconds that the battery life is less than 20 minutes, and then the pump powered down within moments of that. The rn stated that the pump was plugged into power while in storage. As a result, the pump was then plugged into wall power and the pump is pumping fine and supporting the patient. Additional information received from the rn stated that the pump was sent to biomed and checked. The pump was charged overnight and is back in service. There may have been a problem with the power strip the pump was plugged into while in storage. The power strip may have been off. The patient later expired but not related to the intra-aortic balloon pump (iabp) per the statement of a medical professional.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that when transporting a patient from the cath lab to the intensive care unit they unplugged the pump from power and the pump alarmed as it should that it was on battery. It again alarmed within a few seconds that the battery life is less than 20 minutes, and then the pump powered down within moments of that. The rn stated that the pump was plugged into power while in storage. As a result, the pump was then plugged into wall power and the pump is pumping fine and supporting the patient. Additional information received from the rn stated that the pump was sent to biomed and checked. The pump was charged overnight and is back in service. There may have been a problem with the power strip the pump was plugged into while in storage. The power strip may have been off. The patient later expired but not related to the intra-aortic balloon pump (iabp) per the statement of a medical professional.
 
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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 Key7157967
MDR Text Key263121910
Report Number1219856-2017-00326
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 12/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902007247
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 Received02/01/2018
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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