MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML; BLOOD GAS OXYGENATOR

Model Number	3CX*RX15RW30
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code.(b)(4).Results code: results pending completion of evaluation.Conclusions code: conclusion not yet available-evaluation in progress.
Event or Problem Description
The user facility reported to terumo cardiovascular that during prime, a po2 of 330 mmhg was noted during the priming process when the cdi 500 cell was put in-line which is normally above 600mmhg.A sample was drawn off the pump and it was run it on the i-stat blood gas analyzer.The 1st po2 came back at 360mmhg, the sweep gas was turned up to 3 liters per min and checked for cracks/leaks/loose connections in the gas delivery system.The cdi po2 varied between 330-360mmhg.An oxygen tank was then brought to the room and had anesthesia run a gas line from their ventilator through our gas filter and into the oxygenator.The ventilator was set at 100% fio2 with 2 liters per minute of sweep gas.The highest the cdi read was 365mmhg.Another i-stat was ran off the pump and the results came back at 394 mmhg.The oxygenator was changed out.The pump¿s gas delivery system was hooked to the new oxygenator and the cdi 500 still had a low reading of 380mmhg.Another prime sample was drawn and changed the cdi cell.The new cell gave a reading of approximately 400mmhg and the prime gas from the i-stat came back at 535 mmhg.The procedure was completed with the new oxygenator with no issues.No consequences or impact to the patient; product was changed out; procedure was completed successfully.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 17, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The returned sample was visually inspected and there was no obvious anomalies such as a break.The sample, after having been rinsed and dried was built into a circuit with tubes.Pao2 was determined while saline solution was being circulated in the circuit.It was confirmed to be comparable to that of the current product sample.Following this test, the o2 transfer and co2 removal volumes were determined in accordance with that of the factory's shipping test protocol (bovine blood testing).They were verified to meet the specifications.The complaint was not confirmed and a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HOLLOW FIBER OXY WITH 3000 ML
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7794633
• Report Number: 1124841-2018-00187
• Device Sequence Number: 1195514
• Product Code: DTZ
• UDI-Device Identifier: 00699753450127
• UDI-Public: (01)00699753450127
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 3CX*RX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: VK28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 10/02/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/18/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1