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

Catalog Number IAP-0500

Device Problems Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Operating System Version or Upgrade Problem (2997)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Parts were discarded.

Event Description

It has been reported via a field service report: (b)(4). Symptom: op-on patient. Fos is not working. Findings/action taken: perform functional check - confirmed fiber optic sensor (fos) not working. Found and replaced defective fos print circuit board (pcb) and old fos connector. Fos now - checks ok. Fcn level: 1416. Software level: 2. 24. Per the field service engineer, on tuesday (b)(6) 2017 the pump was not recognizing when a fos balloon was inserted. They just swapped the pump with another one and continued as normal. No patient complications. The field service engineer (fse) replaced a defective fos pcb to repair the problem. The board was one of the old style boards. The fos slider was old so he replaced that as well.

Manufacturer Narrative

Teleflex did not receive the device for analysis. The reported complaint of "fos not recognized" was confirmed by the field service engineer. The root cause of the reported complaint is undetermined. A device history record (dhr) review was conducted for the iap serial and lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex will continue to closely monitor.

Event Description

It has been reported via a field service report: l612131. Symptom: op-on patient. Fos is not working. Findings/action taken: perform functional check - confirmed fiber optic sensor (fos) not working. Found and replaced defective fos print circuit board (pcb) and old fos connector. Fos now - checks ok. Fcn level: 1416. Software level: 2. 24. Per the field service engineer, on tuesday (b)(6) 2017 the pump was not recognizing when a fos balloon was inserted. They just swapped the pump with another one and continued as normal. No patient complications. The field service engineer (fse) replaced a defective fos pcb to repair the problem. The board was one of the old style boards. The fos slider was old so he replaced that as well.

• 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: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6360866
• MDR Text Key: 68420803
• Report Number: 1219856-2017-00038
• 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: 02/01/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• 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: 03/29/2017
• 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