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

Catalog Number IAP-0500F

Device Problem Power Problem (3010)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported via a field service report: (b)(4).Symptom: pump turns off in use findings / actions taken: power supply replaced.Pump checked and pass.Software: (b)(4).Reason for service: other reason update on 06/22/2016-per the field service agent "there were no reports of complaints.".

Manufacturer Narrative

Qn#(b)(4).Additional information received 07/18/2016 the pump was on a patient at the time of the event.Pump switched.The condor power supply (p/n: 77-0063-001 s/n: (b)(4)) was returned for evaluation.Visual inspection of condor power supply was performed and found no obvious damage or defects.The condor power supply was installed into a known good autocat2w and functional testing was performed.The pump was startup as normal.A power supply voltage check was performed per autocat2 series service manual (rev 3) and all voltages were within specification.The pump was run on battery (battery load test) until the iabp shut down (>90minutes within spec).A battery load test was performed after letting the pump charge for over 8 hours and the unit ran for over 90 minutes.The condor power supply passed all functional testing.Visual inspection of the condor power supply internal hardware was performed and no component damage or defect was noted.See other remarks section.Other remarks: 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.Conclusion: the reported complaint of "turns off in use" is not confirmed.The reported problem could not be reproduced during the functional test.The power supply passed functional testing.The cause of the reported complaint is undetermined.

Event Description

It has been reported via a field service report: (b)(4).Symptom: pump turns off in use.Findings / actions taken: power supply replaced.Pump checked and pass.Software: 2.24fr.Fcn: (b)(4).Reason for service: other reason.Update on 06/22/2016-per the field service agent "there were no reports of complaints.".

• Brand Name: AUTOCAT2 WAVE FRENCH
• 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: 5773318
• MDR Text Key: 48974433
• Report Number: 1219856-2016-00157
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500F
• Other Device ID Number: 30801902092183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• 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: Unknown
• Patient Sequence Number: 1