MAUDE Adverse Event Report: TELEFLEX MEDICAL PE INFANT SAHARA DRY SUC/ SEAL LF 6/CS; APPARATTUS,AUTOTRANSFUSION

Catalog Number S-1130-08LF

Device Problems Crack (1135); Fracture (1260)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Blood Loss (2597)

Event Date 04/12/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Visual inspection was performed by using the pictures provided.The product code was found and verified that the unit pertains to an s-1130-08lf code (infant); additionally it is visible that the collection chamber is totally filled with blood and collected on the small chamber which is only used for the mentioned model.Verification of the lot number sticker, placed on the back and shown in the picture, 74h1500328 was confirmed that the unit reported belongs to p/n s-1130-08lf (infant) instead of s-1150-08lf as reported in the complaint.The customer complaint alleges that the unit is cracked on the top and during the hook up to the suction port blood came immediately out from the unit.However, the customer indicated that the product was used on an adult male.Code s-1130-08lf (infant model) is designed to collect a capacity of 200ml versus a collection chamber of 2500 ml or 1900ml which is provided on some other different adult models.It is assumed that the reason of having a blood blast could occur during the use of the wrong model.Due to this, a functional issue cannot be related to this complaint.Other remarks: the device history record of batch number 74h1500328 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection reports were originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to the manufacture's specifications.The device history review for s-1130-08lf (infant) showed no issues related to the reported failure mode neither on the product or its components during the manufacture of this material and based on incorrect use of the product, an adult instead of a child, a functional failure cannot be confirmed and corrective action cannot be implemented.The manufacturer will continue to monitor and trend related events.

Event Description

As reported by the hospital: the patient, an adult older gentleman, had a traumatic chest injury.While the surgeon inserted the chest tube the nurse used pre-filled saline to fill the device and connected the device to suction.Once the physician inserted the chest tube there was immediate blood return so he clamped the chest tube as the nurse handed him the sterile tubing for the pleuravac.The suction was turned on prior to handing the sterile tubing to the surgeon to assure that suction was working; the suction was not removed from the device.The nurse got the auto-transfusion system ready, there was no line there, the pleuravac filled up and the top cracked.There was blood pouring out of a crack.The patient was receiving cardiopulmonary resuscitation with manual respiratory support or being bagged.The patient is deceased.

Manufacturer Narrative

(b)(4).Visual inspection was performed by using the pictures provided, the involved unit doesn't show the front part (where the product code is specified) however, it can be observed by looking at the back side and ports, that the unit pertains to a s-1130-08lf code (infant) additionally, it is visible that the collection chamber is totally filled with blood and collected on the small chamber which is only used for the mentioned model.During the verification of the lot number sticker 74h1500328 it was confirmed that unit reported belongs to p/n s-1130-08lf instead of s-1150-08lf as reported in the complaint.Lot quantity: (b)(4) ea.Based in photographs provided, it was not possible to determine whether the top of the unit cracked as reported in this customer complaint.The customer complaint alleges that the unit is cracked in top and during the hook up to the suction port the blood came immediately out from the unit.However the customer indicated that product was used in adult men.Code s-1130-08lf (infant model) is designed to collect a capability of 200ml versus a other remarks: collection chamber of 2500 ml or 1900ml which is provided on some other different adult models.It is assumed that the reason of having a blood blast could occur during the use of a wrong model.Due to this, a functional issue cannot be related to this complaint.The dhr reviewed (s-1130-08lf) showed that there were no issues related to the reported failure mode neither on the product or its components during the manufacture of this material and based in incorrect use of product (in adult instead of children) a functional fail cannot be confirmed and corrective action cannot be implemented also based in photographs provided, it was not possible to determine whether the top of the unit cracked as reported in this customer complaint.

Event Description

As reported by the hospital: the patient, an adult older gentleman, had a traumatic chest injury.While the surgeon inserted the chest tube the nurse used pre-filled saline to fill the device and connected the device to suction.Once the physician inserted the chest tube there was immediate blood return so he clamped the chest tube as the nurse handed him the sterile tubing for the pleuravac.The suction was turned on prior to handing the sterile tubing to the surgeon to assure that suction was working; the suction was not removed from the device.The nurse got the auto-transfusion system ready, there was no line there, the pleuravac filled up and the top cracked.There was blood pouring out of a crack.The patient was receiving cardiopulmonary resuscitation with manual respiratory support or being bagged.The patient is deceased.

• Brand Name: PE INFANT SAHARA DRY SUC/ SEAL LF 6/CS
• Type of Device: APPARATTUS,AUTOTRANSFUSION
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5641670
• MDR Text Key: 44761190
• Report Number: 3004365956-2016-00203
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S-1130-08LF
• Device Lot Number: 74H1500328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death