MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,600X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number	CB6004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
Fill volume: 750 ml, flow rate: 6 ml/hr, procedure: left rotator cuff repair, cathplace: left shoulder.It was reported by the patient's wife that the patient began to experience a metallic taste in his mouth associated with the use of an elastomeric homepump.The patient never experienced any prior side effects until now.The flow rate was initially set at 6 ml/hr and was not changed.The patient was advised to clamp the pump and follow-up with anesthesia on the issue.Anesthesia had the patient keep the pump clamped because they had concerns that the catheter may have migrated.They wanted to perform an evaluation on the patient and propose the possibility of removing and reinserting the catheter.Additionally, they wanted to discuss with the surgeon as to why the patient was still experiencing so much pain so long post-op.Additional information received on 01-feb-2017 from the patient's wife stated that her husband (patient) was doing well and was in stable condition.He was no longer experiencing a metallic taste in his mouth.It resolved 15 minutes after the pump was clamped.However, he was still experiencing pain in his left shoulder, but it is noted to be manageable.He was taking tylenol 3 and percocet.It was clarified that the patient had a left shoulder rotator cuff repair surgery on (b)(6) 2017.The pump was placed and started on (b)(6) 2017, which relieved the patient's pain until he had to cease infusion due to the metallic taste on (b)(6) 2017.The patient's wife called the doctor and spoke to an anesthesiologist, who advised her to clamp the pump and not to remove it.The anesthesiologist believed that the catheter might have migrated to interstitial space.They wanted to evaluate the patient's level of pain and the catheter before discontinuing its use.At the time, the pump had medication remaining inside was described as being about the size of a tennis ball.The pump was carried in a black pouch hanging from around the patient's neck, and the pouch laid at the patient's waist.It was noted that there were no warming devices used, and no pressure was applied to the pump.
Additional Manufacturer Narrative
The pump was returned partially full.The pinch clamp was opened and the pump infused at all selectable flow rates.The tubing was cut below the blue connector to drain the medication.A male and female luer were used with cyclohexanone to bond the tubing back together.The pump was refilled to nominal volume with 600ml of 0.9% saline using a baxa repeater pump.Flow accuracy testing was performed with the saf (select-a-flow) set to 8ml/hr.After 56.25 hours of testing, the pump yielded a flow rate of 4.56ml/hr which is within specifications with a +/- 20% tolerance.The pressure pot was performed on the selected-a-flow unit flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge.The average bladder pressure used was 8.0psi.The saf flow rate 2ml/hr yielded a flow rate of 2.07ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.10ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.92ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.96ml/hr which is within specifications with a +/- 20% tolerance.The evaluation concludes that fast flow was not observed.During the flow accuracy test, the pump was below specification with a +/-20% tolerance.During pressure pot testing, all flow rates met specifications using the average bladder pressure.Root cause could not be determined.All information reasonably known as of 26-may-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: HYHSURGPN,600X2-14,CB SAF,-,OQ,5
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6362573
• Report Number: 2026095-2017-00034
• Device Sequence Number: 673060
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2019
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0202547280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 05/30/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PERCOCET; TYLENOL 3
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 95