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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 02/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the pump was used on a patient and ran for ten minutes. After the alarm was set off, the pump shut off one minute later. As a result the battery was replaced. The field service tech performed functional checks and all functional checks passed. There was no report of patient complication or serious injury and death. The patient remains on the pump with error cleared.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "pump shut off approximately 1 minute" was confirmed by the field service engineer. The battery was replaced and the pump passed all functional checks. The root cause of the battery failure is undetermined. If the device is returned at a later date, a full investigation will be completed. 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.
 
Event Description
It was reported that the pump was used on a patient and ran for ten minutes. After the alarm was set off, the pump shut off one minute later. As a result the battery was replaced. The field service tech performed functional checks and all functional checks passed. There was no report of patient complication or serious injury and death. The patient remains on the pump with error cleared.
 
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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 Key7320228
MDR Text Key101864310
Report Number3010532612-2018-00041
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
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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