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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
Model Number IPN000320
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The field service engineer (fse) was unable to duplicate the error after running the iabp for 2.5 hours.Performed fcn # 17 on system and replaced mforce driver.Ran system for another 3 hours and performed functional checks the on system.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) was on a patient, the iabp had a system error 3 alarm and pumping shut down.The staff tried to clear the error and iabp did not work.As a result, the iabp was swapped out with no issues.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of the system error 3 alarm is confirmed.Upon return, a burnt motor driver connector and cable connector was confirmed.Discoloration consistent with burn damage was noted on the motor driver connector and on the motor driver cable.A capa investigation determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.Other remarks: the field service engineer (fse) was unable to duplicate the error after running the iabp for 2.5 hours.Performed fcn # 17 on system and replaced mforce driver.Ran system for another 3 hours and performed functional checks the on system.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) was on a patient, the iabp had a system error 3 alarm and pumping shut down.The staff tried to clear the error and iabp did not work.As a result, the iabp was swapped out with no issues.There was no report of patient complications, serious injury or death.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10334294
MDR Text Key200692363
Report Number3010532612-2020-00199
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902051715
UDI-Public30801902051715
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000320
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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