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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 Alarm System (1012)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 01/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device / parts will not be returned for evaluation.
 
Event Description
It was reported per field service report: pump was on patient. Symptom: purge failure. Findings/action taken: found system error (1) upon power up. Found "purge failure" (5) when pump on. No bp activity. After removing front end panel system pumps properly. Check all connectors for pcs (pneumatic control switch). Reconnect transducer connector. Check tubing routing. System is functional. Software level: 2. 24.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: no parts or recorder strips were returned to teleflex (b)(4) for evaluation. A device history record (dhr) review could not be completed on the iabp lot number/serial number. The iabp dhr job packet could not be retrieved and is no longer on site. This is a 2003 antocat2 wave pump. A dhr review was conducted for the pcs assembly lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the report of "purge failure" is confirmed by the field service engineer. The transducer connector was reconnected and this resolved the problem. The cause of how the connectors become loose could not be determined.
 
Event Description
It was reported per field service report: pump was on patient. Symptom: purge failure. Findings/action taken: found system error upon power up. Found "purge failure" when pump on. No bp activity. After removing front end panel system pumps properly. Check all connectors for pcs (pneumatic control switch). Reconnect transducer connector. Check tubing routing. System is functional. Software level: 2. 24.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-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 Key5401357
MDR Text Key37238718
Report Number1219856-2016-00026
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 other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2016
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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