MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500

Device Problems Pumping Stopped (1503); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not returned to manufacturer.

Event Description

It was reported via a hot line call to the clinical support specialist (css) that the pump was on a patient and the pump suddenly shut down without warning.The staff toggled the power switch off then on, unplugged and plugged in the ac power cord.Everything was working fine after that.The iabp support was interrupted for a few minutes.The pump was sent to biomed.The biomed wanted some help with battery run time testing to check out the battery which the css provided.There was no patient harm, injury or death reported.

Manufacturer Narrative

(b)(4).No parts or recorder strips were returned for evaluation at the teleflex (b)(4).Follow up information received from the hospital biomed stated that the pump was run over the weekend and the pump passed testing.There was no problem found with the pump.The pump serial number was unknown.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint could not be confirmed.There was no patient injury or death.The hospital staff shut down and rebooted the pump and the pump worked according to design prior to the hot line call.The pump was sent to biomed and the hospital biomed checked the battery run time over the weekend and found no issues with the pump.The pump was operational and functioned as designed.The cause of the pump suddenly shutting down is undetermined.

Event Description

It was reported via a hot line call to the clinical support specialist (css) that the pump was on a patient and the pump suddenly shut down without warning.The staff toggled the power switch off then on, unplugged and plugged in the ac power cord.Everything was working fine after that.The iabp support was interrupted for a few minutes.The pump was sent to biomed.The biomed wanted some help with battery run time testing to check out the battery which the css provided.There was no patient harm, injury or death reported.

• Brand Name: AUTOCAT2 WAVE
• 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: 6079352
• MDR Text Key: 59230611
• Report Number: 1219856-2016-00242
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/10/2016

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-0500
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• 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: Unknown
• Patient Sequence Number: 1