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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 Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No sample components were received by manufacturer.
 
Event Description
It was reported via a hot line call the patient is (b)(6) tall. They placed the iab on the second cath lab procedure. The pump (b)(4) failed to restart related to pump valve controller failure. The registered nurse (rn) called the clinical support specialist to assist after she connected the fos to the second pump s/n (b)(4). The css walked the rn through changing connections from the first pump s/n (b)(4) to the second pump. There was a reported 10 minute delay. The pump is using the transducer and supporting the patient appropriately. The pump was to be flagged and sent to biomed with a note as to what the alarm said. The css received no further calls related to this patient.
 
Manufacturer Narrative
(b)(4). No parts or recorder strips were returned to teleflex (b)(4) for evaluation. Per the call report, the rn stated that the pump failed to restart (related to pump valve controller failure) after the patient required brief rounds of compressions. The pump was exchanged for a second pump and flagged to be sent to biomed. The hospitals biomed do their own repairs. They do not have a service contract. No service was provided to the pump. Additional information received from world wide support stated that this customer is a demand customer and a contract quote was given to them on (b)(6). No further information was received. No further action taken. A device history record (dhr) review was conducted for the iap lot/serial numbers with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of "alarm, system error 3" is not confirmed. The biomed department does their own repairs. No service was provided to the pump. No parts or recorder strips were returned to teleflex (b)(4) for evaluation. The cause of reported complaint is undetermined.
 
Event Description
It was reported via a hot line call the patient is 5'9" tall. They placed the iab on the second cath lab procedure. The pump (b)(4) failed to restart related to pump valve controller failure. The registered nurse (rn) called the clinical support specialist to assist after she connected the fos to the second pump s/n (b)(4). The css walked the rn through changing connections from the first pump s/n (b)(4) to the second pump. There was a reported 10 minute delay. The pump is using the transducer and supporting the patient appropriately. The pump was to be flagged and sent to biomed with a note as to what the alarm said. The css received no further calls related to this patient.
 
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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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6019045
MDR Text Key57055158
Report Number1219856-2016-00218
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K0603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2016
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 Received10/19/2016
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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