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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problems No Display/Image (1183); Pumping Stopped (1503)
Patient Problem Myocardial Infarction (1969)
Event Date 02/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the rn from the cath lab was calling to report that the intra-aortic balloon pump (iabp) had a "main cpu failure" last night.The rn stated that "at start-up of pump" the screen went blank and the pump powered down.They replaced the pump with another and were able to continue with the procedure with no further issues.The clinical support specialist (css) first verified that they were able to support the patient with a different pump and that there was only a minimal delay of "about two minutes" to replace the pump.The css then asked if they had tried to power the original pump back on since the incident and the rn stated that they did successfully power it on.The css recommended that they have the original pump checked by biomed prior to returning it to service.
 
Manufacturer Narrative
(b)(4) device evaluation: the cpu (central processing unit) board was returned for evaluation.Visual inspection of the cpu board was performed and no abnormalities were found.The cpu board in question was installed onto the cpu/fe/fos board test fixture and the functional test was performed.No faults were found.The cpu board passed testing.The cpu board was then installed into a known good intra-aortic balloon pump ((b)(4)) and functional testing was performed.The pump was powered up successfully without any issues.The pump with cpu board in question passed all functional testing.The pump was then left to run for six hours and no alarms or errors occurred.No device history record required.No problem found on the returned sample.Conclusion: the reported complaint of "display screen went blank" is not confirmed.The reported problem could not be replicated at teleflex (b)(4) facility during the functional test.The cause of reported alarm is undetermined.
 
Event Description
It was reported that the rn from the cath lab was calling to report that the intra-aortic balloon pump (iabp) had a "main cpu failure" last night.The rn stated that "at start-up of pump" the screen went blank and the pump powered down.They replaced the pump with another and were able to continue with the procedure with no further issues.The clinical support specialist (css) first verified that they were able to support the patient with a different pump and that there was only a minimal delay of "about two minutes" to replace the pump.The css then asked if they had tried to power the original pump back on since the incident and the rn stated that they did successfully power it on.The css recommended that they have the original pump checked by biomed prior to returning it to service.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
INTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5494726
MDR Text Key40142072
Report Number1219856-2016-00060
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
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2016
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 Unknown
Patient Sequence Number1
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