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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 Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report: (b)(4).Symptom: (pm)preventative maintenance due to high baseline alarm and system (3) error alarm.The iabp was on a patient but swapped quickly and did not harm patient.Findings / actions taken: found high baseline alarm then system (3) error alarm.Replaced p/s.Did not fix problem.Put old p/s back in.Replaced stepper motor controller did not fix problem.Reinstalled old stepper motor controller.Replaced pump assy fixing problem.Performed pm and functional check list.Iabp perform to spec.Fcn level: (b)(4).Software level: (b)(4).
 
Manufacturer Narrative
(b)(4) the pump assembly (p/n: 77-3200-001, s/n: (b)(4)) was returned for evaluation.Visual inspection of pump assembly was performed and found no obvious damage or defects.The pump assembly in question was installed into known good autocat2w and the functional testing was performed.When pumping was initiated the iabp alarmed with high baseline and then system error 3.Further evaluation of the pump assembly was performed and found the stepping motor to be faulty part.A known good stepper motor was installed into the pump assembly in question, and then installed in to known good autocat2w.The iabp passed the functional test.This is the original pump assembly of this 2005 iabp.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.Conclusion: the reported complaint of "unit alarmed high baseline and system error 3" is confirmed.The problem was duplicated during the functional test.The stepper motor of the pump assembly was found to be the cause of report problem.The root cause of the stepping motor malfunctioned cannot be determined.
 
Event Description
It was reported via a field service report: (b)(4).Symptom: (pm)preventative maintenance due to high baseline alarm and system (3) error alarm.The iabp was on a patient but swapped quickly and did not harm patient.Findings / actions taken: found high baseline alarm then system (3) error alarm.Replaced p/s.Did not fix problem.Put old p/s back in.Replaced stepper motor controller did not fix problem.Reinstalled old stepper motor controller.Replaced pump assy fixing problem.Performed pm and functional check list.Iabp perform to spec.Fcn level: 16.Software level: 2.24.
 
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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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5783540
MDR Text Key49238140
Report Number1219856-2016-00156
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2016
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 Manufacturer07/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2016
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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