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

Catalog Number IAP-0500I

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via an external quality review (eqr) report. Symptom: white monitor, they were able to swap it with another functioning one from another iap until the tech arrival actions: the monitor has been replaced due to problems with the lcd op
=
on patient.

Manufacturer Narrative

(b)(4). Additional information received: the pump was not switched off the pump a monitor from another pump was used. There was no interruption in therapy. Patient outcome is unknown. Investigation: the display head assembly was returned for evaluation. Visual inspection of display head cable was performed and noted some water marks on the screen and a missing logo. No other abnormality was noted. The display head assembly was installed onto a known good autocat2w. The display head assembly failed functional testing. The pump displayed blank screen on power-up. Visual inspection of the display head assembly internal hardware was performed. A missing screw after latch was removed and loose connection of the lcd module and keypad assembly were noted. The loose cable was reseated and the display head assembly was then installed onto a known good autocat2w. The system was power up successfully with no issues. The full functional test was performed and passed. The pump was then left to run for over 2 hours and no alarms or errors were occurred. See other remarks section. Other remarks: a device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The risk for display screen failure was reviewed and is acceptable. Conclusion: the reported complaint of "blank display" is confirmed. The reported problem was replicated at teleflex (b)(4) during the functional test. A loose cable connection was found inside the display head assembly and that caused the reported complaint. The reported problem was corrected after reseating the cable. The cause of the loose cable is undetermined.

Event Description

It was reported via an external quality review (eqr)report. Symptom: white monitor, they were able to swap it with another functioning one from another iap until the tech arrival actions: the monitor has been replaced due to problems with the lcd. Op
=
on patient.

• Brand Name: AUTOCAT2 WAVE ITALIAN
• 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: 6122650
• MDR Text Key: 60763190
• Report Number: 1219856-2016-00264
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0500I
• Other Device ID Number: 30801902092190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown