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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 Low Battery (2584); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "pump shut off on battery power" is not able to be confirmed. The pump was due for preventative maintenance, therefor, the hospital biomed replaced the battery. 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.
 
Event Description
It was reported by the rn that during patient transport to the radiology department, the battery on the pump "died" on the way back. The rn called the clinical support specialist (css) to ask about changing out the battery while it is running on the patient. The css explained to the rn that it is not possible to change the battery out while it is running on the patient. The rn stated that there was no harm to the patient during all of this. They discussed changing the pump out, and then sending this pump to bio-med to have the battery replaced there if necessary. There was no patient death or serious injury. No medical intervention was required. Additional information received from the charge nurse stated the pump was not switched off the patient. The patient remained on the pump until the next day and the pump was then discontinued. Patient outcome was fine. Pump was sent to biomed to have the battery changed out.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that during patient transport to the radiology department, the battery on the pump "died" on the way back. The rn called the clinical support specialist (css) to ask about changing out the battery while it is running on the patient. The css explained to the rn that it is not possible to change the battery out while it is running on the patient. The rn stated that there was no harm to the patient during all of this. They discussed changing the pump out, and then sending this pump to bio-med to have the battery replaced there if necessary. There was no patient death or serious injury. No medical intervention was required. Additional information received from the charge nurse stated the pump was not switched off the patient. The patient remained on the pump until the next day and the pump was then discontinued. Patient outcome was fine. Pump was sent to biomed to have the battery changed out.
 
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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 Key7156645
MDR Text Key268923112
Report Number1219856-2017-00322
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 12/05/2017
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 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 Received01/31/2018
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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