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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 Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported via a field service report (b)(4): symptom: using a slave cable, to bring electrocardiogram (ecg) into pump, the electrocardiogram (ecg) signal would drop out intermittently. Findings/action taken: (b)(6) 2016 checked out system found loose cable on cpu board (j2). Could not duplicate problem. Need to replace front end board. On (b)(6) 2016 checked system, replaced front end board, checked all inputs and outputs (high & low). Ran pump for 2 hours after board replaced. Biomed performed electrical safety check. Reason for service: repair. Eqr condition: op - on patient. Unconfirmed. More information received from the perfusionist stated that the patient came down to the operating room (or) and was put on a slave cable. The patient was on the pump for about 1 hour with no problem, and then there was an electrocardiogram (ecg) signal issue. They tried troubleshooting with cabling, but had to switch the pump out. There was no patient harm.
 
Manufacturer Narrative
Qn#(b)(4). Evaluation: the affected front end board device was returned to teleflex for analysis. An inspection using a known good autocat2w was used and no abnormalities were found. The device passed functional testing. Conclusion: the reported complaint of "ecg signal drop out intermittently" is not confirmed. The reported problem could not be replicated at the teleflex (b)(4) facility during the functional test. Teleflex will continue to monitor for similar reports of this issue.
 
Event Description
It has been reported via a field service report l610209: symptom: using a slave cable, to bring electrocardiogram (ecg) into pump, the electrocardiogram (ecg) signal would drop out intermittently. Findings/action taken: 11-11-16 checked out system found loose cable on cpu board (j2). Could not duplicate problem. Need to replace front end board. 11-14-16 checked system, replaced front end board, checked all inputs and outputs (high & low). Ran pump for 2 hours after board replaced. Biomed performed electrical safety check. Reason for service: repair. Eqr condition: op - on patient unconfirmed. More information received from the perfusionist stated that the patient came down to the operating room (or) and was put on a slave cable. The patient was on the pump for about 1 hour with no problem, and then there was an electrocardiogram (ecg) signal issue. They tried troubleshooting with cabling, but had to switch the pump out. There was no patient harm.
 
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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
carmen sherman
3015 carrington mill blvd
morrisville 27560
MDR Report Key6140914
MDR Text Key61310314
Report Number1219856-2016-00275
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? No
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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