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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 Problem Low Battery (2584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of "short battery run time" is not confirmed. Although, the root cause of the reported complaint remains undetermined the power supply passed functional testing. The complaint will be monitored for developing trends. Per operator's manual "the battery should be maintained at full charge whenever possible. Arrow international recommends that the autocat2 series iabp be kept plugged into a proper ac receptacle whenever possible including time when the unit is in storage or not in use. The power indicator will illuminate when ac power is present. The batteries should not be stored in a discharged state. " 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. No further action required.
 
Event Description
It was reported via field service report l612180 that the pump had a short battery run time while on a patient. Additional information received from the field service agent stated the pump seemed to run ok in battery with the battery still strong at 22 minutes of run time. At 24 minutes the pump began to die quickly. At 25 minutes of operation, the 20 minutes left alarm came on and the pump shut down at the time. The pump was switched out with no harm to the patient. The fse replaced the defective battery.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via field service report l612180 that the pump had a short battery run time while on a patient. Additional information received from the field service agent stated the pump seemed to run ok in battery with the battery still strong at 22 minutes of run time. At 24 minutes the pump began to die quickly. At 25 minutes of operation, the 20 minutes left alarm came on and the pump shut down at the time. The pump was switched out with no harm to the patient. The fse replaced the defective battery.
 
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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.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6803393
MDR Text Key246686265
Report Number1219856-2017-00183
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 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Yes
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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