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

Catalog Number IAP-0500

Device Problem Failure to Charge (1085)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report: (b)(4).Symptom: no power from power supply.User ran pump but was on battery power until shut off.Pump swapped quickly and did not harm patient.Findings/action taken: found, while plugged in, indictor lights not on, no fans running, and no charging voltage.Checked fuse, all connections, ac input module, all did not fix problem.Replaced power supply.Found battery was at 12.37v, new charging normally at 13.34v.Performed functional checklist.Iabp perform to spec.Fcn level: 16, software level: 2.24.Op = on patient, confirmed.

Manufacturer Narrative

Qn#(b)(4).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 ac was not present and no light indicators were not lid up when the pump was turned on.The pump was also alarmed "system running on battery power".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 until it shut down.Then let the pump charge for over 9 hours.The pump then failed to turn on.The condor power supply failed all functional testing.A power supply voltage check was performed per autocat2 series service manual (rev 3) and failed voltages check.All output voltages were measured at 0 volt.See other remarks section.Other remarks: visual inspection of the condor power supply internal hardware was performed and no component damage or defects were noted.This is condor power supply was replaced on january 4th, 2005.Conclusion: the reported complaint of "no power from power supply" is confirmed.The reported problem was reproduced during the functional test.The power supply failed functional testing.The cause of the reported power supply malfunction is undetermined.

Event Description

It was reported via a field service report: (b)(4).Symptom: no power from power supply.User ran pump but was on battery power until shut off.Pump swapped quickly and did not harm patient.Findings/action taken: found, while plugged in, indictor lights not on, no fans running, and no charging voltage.Checked fuse, all connections, ac input module, all did not fix problem.Replaced power supply.Found battery was at 12.37v, new charging normally at 13.34v.Performed functional checklist.Iabp perform to spec.Fcn level: 16, software level: 2.24.Op = on patient, confirmed.

• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5950814
• MDR Text Key: 54763517
• Report Number: 1219856-2016-00207
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: 0001102349
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2003
• 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