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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AEROAUTOCAT2 SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0435
Device Problems Device Alarm System (1012); Low Battery (2584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via field service report #(b)(4). While during use on a patient, the pump gave 20 minute alarm being unplugged. The pump was checked by the field service agent and the pump passed the battery load test. The reported symptom of the pump gave 20 minute alarm being unplugged could not be duplicated. The pump was returned to service. Additional information: the field service engineer (fse) reported that "when they got the alarm on the landing pad, they were able to run up to the patients room and get it plugged in". There were no reported patient complications.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "pump gave 20 minutes alarm after being unplugged" 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 via field service report #l701101. While during use on a patient, the pump gave 20 minute alarm being unplugged. The pump was checked by the field service agent and the pump passed the battery load test. The reported symptom of the pump gave 20 minute alarm being unplugged could not be duplicated. The pump was returned to service. Additional information: the field service engineer (fse) reported that "when they got the alarm on the landing pad, they were able to run up to the patients room and get it plugged in". There were no reported patient complications.
 
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Brand NameAEROAUTOCAT2
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 Key7274883
MDR Text Key100447029
Report Number3010532612-2018-00018
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 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0435
Other Device ID Number00801902051745
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 Received03/20/2018
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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