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

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".

• Brand Name: AEROAUTOCAT2 WAVE JAPANES
• 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 Key: 5837897
• MDR Text Key: 50909281
• Report Number: 1219856-2016-00165
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0535J
• Device Lot Number: 0001073242
• Other Device ID Number: 30801902091780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1