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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2 WAVE JAPANES INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AEROAUTOCAT2 WAVE JAPANES INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0535J
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sample has not been returned.
 
Event Description
"it has been reported that during use an electronic sparks "flied" and the ac plug and power cord melted and deformed by the sparks. As a result the pump was replaced by another pump (a stand-by pump). No health injury was reported. There is no information whether this event occurred while the pump was connected to a patient. " the patient outcome was listed as "good".
 
Manufacturer Narrative
(b)(4). Additional information was received on 8/8/16 that the pump was on a patient at the time of the event. According, to the dealer the user medical staff didn't apply any additional force to ac cable. (example: stepping on cable by foot, pinching/hold cable with apparatus) when the sparks began, the pump was switched to the battery power and pumping was continued. As a result of this event, the pump was replaced by a hospital's standby pump. There were no health injury issues. No medical/surgical intervention was required. Evaluation: no iap parts or recorder strips were returned for evaluation at the (b)(4) teleflex facility. The reported complaint stated that there was an electronic spark which melted the ac plug (6 amp filter) and power cord. Pictures received and reviewed indicated that the 6 amp filter and non-arrow power cord were melted. The 6 amp filter fuse was damaged/blown and the housing was melted. This may have occurred during a power surge which would have melted and damaged the 6 amp filter and non-arrow power cable. See other remarks section. Other remarks: multiple attempts were made to fukuda for the return of the parts to no avail. If the parts are returned, the complaint file will be reopened and a full investigation will be performed. A device history record (dhr) review was conducted for the iap serial number and lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of an electronic spark melting the ac receptacle and power cord is confirmed based on the details provided to teleflex japan and pictures received. The pictures indicated that the amp filter (ac receptacle) and non-arrow power cord were damaged/ melted. No iap parts or recorder strips were returned for evaluation at the (b)(4) teleflex facility. The cause of the reported complaint is undetermined.
 
Event Description
"it has been reported that during use an electronic sparks "flied" and the ac plug and power cord melted and deformed by the sparks. As a result the pump was replaced by another pump (a stand-by pump). No health injury was reported. There is no information whether this event occurred while the pump was connected to a patient. " the patient outcome was listed as "good".
 
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Brand NameAEROAUTOCAT2 WAVE JAPANES
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 Key5837897
MDR Text Key50909281
Report Number1219856-2016-00165
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0535J
Device Lot Number0001073242
Other Device ID Number30801902091780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2008
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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