MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0435

Device Problems Device Alarm System (1012); Low Battery (2584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via field service report #(b)(4).While during use on a patient, the pump gave 20 minute alarm being unplugged.The pump was checked by the field service agent and the pump passed the battery load test.The reported symptom of the pump gave 20 minute alarm being unplugged could not be duplicated.The pump was returned to service.Additional information: the field service engineer (fse) reported that "when they got the alarm on the landing pad, they were able to run up to the patients room and get it plugged in".There were no reported patient complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "pump gave 20 minutes alarm after being unplugged" is not able to be confirmed.The pump was checked by the hospital biomed, could not replicate the battery problem.The root cause of the complaint is undetermined.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported via field service report #l701101.While during use on a patient, the pump gave 20 minute alarm being unplugged.The pump was checked by the field service agent and the pump passed the battery load test.The reported symptom of the pump gave 20 minute alarm being unplugged could not be duplicated.The pump was returned to service.Additional information: the field service engineer (fse) reported that "when they got the alarm on the landing pad, they were able to run up to the patients room and get it plugged in".There were no reported patient complications.

• Brand Name: AEROAUTOCAT2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7274883
• MDR Text Key: 100447029
• Report Number: 3010532612-2018-00018
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0435
• Other Device ID Number: 00801902051745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• 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