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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 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during patient transport across town the intra-aortic balloon pump (iabp) ran well for 20 minutes. Then the 20 minute alarm came on and the battery shut the pump down. The unit was then plugged in and ran fine. The medical staff was able to complete the transport without a problem. The pump did stop and turn off prior to the pump being plugged in. There was no patient death, serious injury or patient complication reported.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The root cause of the battery failure is undetermined. The reported complaint of "pump shut off on battery power after 20 minutes of pumping" was confirmed by the field service agent (fsa). The fsa replaced the battery and returned the pump to service. 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 at this time. The reported complaint will be monitored for any developing trends.
 
Event Description
It was reported that during patient transport across town the intra-aortic balloon pump (iabp) ran well for 20 minutes. Then the 20 minute alarm came on and the battery shut the pump down. The unit was then plugged in and ran fine. The medical staff was able to complete the transport without a problem. The pump did stop and turn off prior to the pump being plugged in. There was no patient death, serious injury or patient complication reported.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The root cause of the battery failure is undetermined. The reported complaint of "pump shut off on battery power after 20 minutes of pumping" was confirmed by the field service agent (fsa). The fsa replaced the battery and returned the pump to service. 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 at this time. The reported complaint will be monitored for any developing trends. Other remarks: this complaint has been reopened to investigate the device that has been returned to teleflex for investigation. The reported complaint of "short battery run time" is confirmed. The battery failed the battery load test. The pump shut off approximately 17 minutes after pumping was initiated, while running on battery power. A definitive root cause could not be determined but a potential cause of the short battery life is a result of maintaining the battery. Per the operator's manual, battery life is dependent on usage and maintenance of the battery. A device history record (dhr) review was conducted for the lot/serial with no relevant findings. No further action required at this time. This will be monitored for any developing trends.
 
Event Description
It was reported that during patient transport across town the intra-aortic balloon pump (iabp) ran well for 20 minutes. Then the 20 minute alarm came on and the battery shut the pump down. The unit was then plugged in and ran fine. The medical staff was able to complete the transport without a problem. The pump did stop and turn off prior to the pump being plugged in. There was no patient death, serious injury or patient complication reported.
 
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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
rachele pierre
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7538142
MDR Text Key109107773
Report Number3010532612-2018-00141
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Other Device ID Number00801902051714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
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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