MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0535

Device Problems Low Battery (2584); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during ground transporting the patient to a hospital, the screen began to flash on and off, and the pump then s topped "augmenting". The pump stopped pumping in use, but did not power down. The transport team then powered the pump off and then back on. The displayed came back on as usual, and was displaying all the normal parameters. When they attempted to resume pumping, the screen again started to flash on and off, and the pump would not resume pumping. The patient was switched to the receiving facilities pump and then resumed as usual. The patient was stable with no complications.

Manufacturer Narrative

(b)(4). Teleflex did not received the device for investigation therefore the reported complaint of "the pump stop pumping" is not able to be confirmed. The field service engineer checked the pump and could not replicate the problem. The root cause of the reported complaint is undetermined. If the parts are returned at a later date, a full investigation will be completed. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. This complaint will be monitored for any developing trends. No further action required at this time.

Event Description

It was reported that during ground transporting the patient to a hospital, the screen began to flash on and off, and the pump then s topped "augmenting". The pump stopped pumping in use, but did not power down. The transport team then powered the pump off and then back on. The displayed came back on as usual, and was displaying all the normal parameters. When they attempted to resume pumping, the screen again started to flash on and off, and the pump would not resume pumping. The patient was switched to the receiving facilities pump and then resumed as usual. The patient was stable with no complications.

• Brand Name: AEROAUTOCAT 2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6855975
• MDR Text Key: 85784669
• Report Number: 1219856-2017-00193
• 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

• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0535
• Other Device ID Number: 00801902051738
• 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 Received: 10/04/2017
• 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